FDA Product Code
FDA Product Code DQA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2700
510(k) Clearances — 727 records · page 6 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K993979 | MARSPO2, MODEL 2001 | Novametrix Medical Systems, Inc. | 2000-02-22 | Abbreviated | PDF ↗ |
| K992455 | NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES | Nihon Kohden America, Inc. | 2000-01-07 | Traditional | PDF ↗ |
| K992211 | SPO2 WRAP SENSOR | Epic Medical Equipment Services, Inc. | 1999-12-22 | Traditional | PDF ↗ |
| K992092 | STAT-SHELL DISPOSABLE SPO2 SENSOR | Epic Medical Equipment Services, Inc. | 1999-12-22 | Traditional | PDF ↗ |
| K981655 | SPACELABS MEDICAL DISPOSABLE SP02 SENSOR | Spacelabs Medical, Inc. | 1999-12-03 | Traditional | PDF ↗ |
| K993637 | N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS | Nellcor Puritan Bennett, Inc. | 1999-11-24 | Special | PDF ↗ |
| K993555 | MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES | Masimo Corp. | 1999-11-19 | Special | PDF ↗ |
| K992238 | MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12) | Masimo Corp. | 1999-10-08 | Traditional | PDF ↗ |
| K992340 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE | Masimo Corp. | 1999-10-08 | Traditional | PDF ↗ |
| K991823 | N-395 PULSE OXIMETER, MODEL N-395 | Nellcor Puritan Bennett, Inc. | 1999-08-25 | Traditional | PDF ↗ |
| K991819 | MAGNATEK 30 | Magna Advanced Technologies, Inc. | 1999-08-19 | Traditional | PDF ↗ |
| K991410 | 3402 HANDHELD PULSE OXIMETER | Bci Intl., Inc. | 1999-06-09 | Traditional | PDF ↗ |
| K990966 | MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS | Masimo Corp. | 1999-06-07 | Traditional | PDF ↗ |
| K991661 | SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 1999-05-28 | Special | PDF ↗ |
| K990082 | EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 | Epic Medical Equipment Services, Inc. | 1999-04-09 | Traditional | PDF ↗ |
| K982728 | NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C | Nellcor Puritan Bennett, Inc. | 1998-12-07 | Traditional | PDF ↗ |
| K983684 | DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS | Datex-Ohmeda, Inc. | 1998-11-06 | Special | PDF ↗ |
| K982776 | 9303 NEONATAL/ADULT VITAL SIGNS MONITOR | Cas Medical Systems, Inc. | 1998-11-02 | Traditional | PDF ↗ |
| K982255 | MODEL 2000 PULSE OXIMETER | Ivy Biomedical Systems, Inc. | 1998-10-22 | Traditional | PDF ↗ |
| K973970 | SPO2 FINGER PROBES | Medical Cables, Inc. | 1998-10-06 | Traditional | PDF ↗ |
| K982907 | MAGNATEK 40 | Magna Advanced Technologies, Inc. | 1998-10-02 | Traditional | PDF ↗ |
| K982405 | MTEK-1000 | Magna Advanced Technologies, Inc. | 1998-09-17 | Traditional | PDF ↗ |
| K982331 | KELLER PULSE OXIMETER, MODEL 850+ | Keller Medical Specialties Products, Inc. | 1998-09-11 | Traditional | PDF ↗ |
| K981939 | AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR | Bci Intl., Inc. | 1998-08-20 | Traditional | PDF ↗ |
| K980879 | OSCILLOMATE NIBP / SP02 EMS MONITOR | Cas Medical Systems, Inc. | 1998-07-16 | Traditional | PDF ↗ |
| K974292 | NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES | Nihon Kohden America, Inc. | 1998-06-08 | Traditional | PDF ↗ |
| K970098 | E100 SERIES SPO2 SENSORS | Epic Medical Equipment Services, Inc. | 1998-04-30 | Traditional | PDF ↗ |
| K980299 | APEX OXIMETER | Marquette Medical Systems, Inc. | 1998-04-24 | Traditional | PDF ↗ |
| K980714 | BCI 3401 HANDHELD PULSE OXIMETER | Bci Intl., Inc. | 1998-03-25 | Traditional | PDF ↗ |
| K973991 | METRON QA-510 SPO2 ANALYZER | Metron U.S., Inc. | 1998-01-16 | Traditional | PDF ↗ |
| K973887 | MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 1998-01-08 | Traditional | PDF ↗ |
| K973147 | NPB-295 PULSE OXIMETER | Nellcor Puritan Bennett, Inc. | 1997-11-14 | Traditional | PDF ↗ |
| K972829 | CRICKET 2000 RECORDING PULSE OXIMETER | Respironics, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K972837 | NPB-290 PULSE OXIMETER (NPB-290) | Nellcor Puritan Bennett, Inc. | 1997-10-21 | Traditional | PDF ↗ |
| K972786 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366 | Alexander Mfg. Co. | 1997-10-17 | Traditional | PDF ↗ |
| K971628 | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) | Somanetics Corp. | 1997-10-10 | Traditional | PDF ↗ |
| K971273 | INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF | Bio-Tek Instruments, Inc. | 1997-10-08 | Traditional | PDF ↗ |
| K970061 | ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) | Datascope Corp. | 1997-09-25 | Traditional | PDF ↗ |
| K972468 | NPB-195 PULSE OXIMETER | Nellcor Puritan Bennett, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K973222 | SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 1997-09-04 | Traditional | PDF ↗ |
| K970769 | COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR | Aristo Medical | 1997-08-28 | Traditional | PDF ↗ |
| K971946 | NPB-190 PULSE OXIMETER (NPB-190) | Nellcor Puritan Bennett, Inc. | 1997-08-25 | Traditional | PDF ↗ |
| K971828 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115 | Alexander Mfg. Co. | 1997-08-12 | Traditional | PDF ↗ |
| K971827 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764 | Alexander Mfg. Co. | 1997-08-12 | Traditional | PDF ↗ |
| K965172 | OXIMETER PRE-AMP CABLE | Epic Medical Equipment Services, Inc. | 1997-07-16 | Traditional | PDF ↗ |
| K964821 | COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 | Ventrex, Inc. | 1997-07-16 | Traditional | PDF ↗ |
| K970763 | MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR | Medical Data Electronics | 1997-07-14 | Traditional | PDF ↗ |
| K971235 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W | Alexander Mfg. Co. | 1997-06-05 | Traditional | PDF ↗ |
| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | Quinton, Inc. | 1997-05-21 | Traditional | PDF ↗ |
| K970368 | SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 1997-05-06 | Traditional | PDF ↗ |
| K964055 | FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) | Epic Medical Equipment Services, Inc. | 1997-02-21 | Traditional | PDF ↗ |
| K945290 | 8500A PULSE OXIMETER | Nonin Medical, Inc. | 1997-02-11 | Traditional | PDF ↗ |
| K962603 | MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES | Masimo Corp. | 1997-02-06 | Traditional | PDF ↗ |
| K963707 | NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) | Nellcor Puritan Bennett, Inc. | 1996-12-13 | Traditional | PDF ↗ |
| K952315 | SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE | Emg Scientific | 1996-12-04 | Traditional | PDF ↗ |
| K963496 | OXI TEMP | Bci Intl., Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K962127 | OHMEDA 3800 PULSE OXIMETER | Ohmeda Medical | 1996-10-10 | Traditional | PDF ↗ |
| K954168 | E100A PULSE OXIMETER FINGER SENSOR/PROBE | Epic Medical Equipment Services, Inc. | 1996-09-12 | Traditional | PDF ↗ |
| K962156 | 3304 PULSE OXIMETER | Bci Intl., Inc. | 1996-08-28 | Traditional | PDF ↗ |
| K961450 | SCORE SOFTWARE | Nellcor Puritan Bennett, Inc. | 1996-08-01 | Traditional | PDF ↗ |
| K960614 | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) | Somanetics Corp. | 1996-06-05 | Traditional | PDF ↗ |
| K960058 | OXITEMP, 3301T SA | Bci Intl., Inc. | 1996-05-15 | Traditional | PDF ↗ |
| K954267 | BURDICK 200 PULSE OXIMETER | Burdick, Inc. | 1996-05-03 | Traditional | PDF ↗ |
| K960251 | COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR | Aristo Medical Products, Inc. | 1996-03-26 | Traditional | PDF ↗ |
| K940933 | 9267 SPO2 ATHENA MODULE | S & W Medico Teknik | 1995-11-29 | Traditional | PDF ↗ |
| K953817 | ARISTO MEDICAL MODEL 2101 PATIENT MONITOR | Aristo Medical Products, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K953126 | OXILINK (SMALL, MEDIUM, LARGE) | Bci Intl., Inc. | 1995-09-21 | Traditional | PDF ↗ |
| K952327 | SMARTSAT PULSE OXIMETRY ANALYZER | Clinical Dynamics Corp. | 1995-08-25 | Traditional | PDF ↗ |
| K952316 | NELLCOR SYMPHONY N-3000 PULSE OXIMETER | Nellcor, Inc. | 1995-08-17 | Traditional | PDF ↗ |
| K952222 | NELLCOR N-20PA PORTABLE PULSE OXIMETER | Nellcor, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K945754 | NEWOX2 | Bci Intl., Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K942347 | NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 | Nellcor, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K943842 | PULSE OXIMETER MODEL 305 | Palco Laboratories, Inc. | 1995-03-24 | Traditional | PDF ↗ |
| K946185 | 3301T OXITEMP | Bci Intl., Inc. | 1995-03-17 | Traditional | PDF ↗ |
| K942842 | HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE | Hewlett-Packard GmbH | 1995-02-16 | Traditional | PDF ↗ |
| K945464 | FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE | Fukuda Denshi USA, Inc. | 1995-02-01 | Traditional | PDF ↗ |
| K942248 | MINIATURIZED FINGER CLIP PULSE OXIMETER | Nonin Medical, Inc. | 1994-12-08 | Traditional | PDF ↗ |
| K943817 | MARQUETTE ADULT/NEONATAL WRAP SENSOR | Marquette Electronics, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K943456 | AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT | Datex Division Instrumentarium Corp. | 1994-10-17 | Traditional | PDF ↗ |
| K943404 | 3301 PULSE OXIMETER | Bci Intl., Inc. | 1994-10-13 | Traditional | PDF ↗ |
| K941351 | BURDICK PRO2 OXIMETER | Burdick Corp. | 1994-10-13 | Traditional | PDF ↗ |
| K944608 | HP M1722A/B AND M1723A/B CODEMASTER | Hewlett-Packard Co. | 1994-10-04 | Traditional | PDF ↗ |
| K931304 | OHMEDA HAND HELD OXIMETER | Ohmeda Medical | 1994-09-29 | Traditional | PDF ↗ |
| K933519 | INDEX SPO2 SIMULATOR | Bio-Tek Instruments, Inc. | 1994-09-01 | Traditional | PDF ↗ |
| K933755 | SENSOR SHIELD, MODIFICATION | Medical Taping Systems, Inc. | 1994-08-16 | Traditional | PDF ↗ |
| K932203 | VITALMAX 530 | Pace Tech Medical Monitors, Inc. | 1994-07-19 | Traditional | PDF ↗ |
| K935510 | VX4 RECORDING PULSE OXIMETER | Vitalog Monitoring,Inc. | 1994-07-01 | Traditional | PDF ↗ |
| K941289 | PULSE OXIMETER | Bci Intl., Inc. | 1994-06-22 | Traditional | PDF ↗ |
| K920083 | BIOCHEM MODEL 3302 NEWOX2 OXIMETER | Biochem International, Inc. | 1994-04-11 | Traditional | PDF ↗ |
| K921454 | FUKUDA DENSHI MODEL HG-301 | Fukuda Denshi USA, Inc. | 1994-04-01 | Traditional | PDF ↗ |
| K934091 | OXISAT | Marquette Electronics, Inc. | 1994-03-15 | Traditional | PDF ↗ |
| K940463 | NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS | Nonin Medical, Inc. | 1994-03-14 | Traditional | PDF ↗ |
| K924626 | NOVAMETRIX MODEL 510 | Novametrix Medical Systems, Inc. | 1993-12-03 | Traditional | PDF ↗ |
| K924752 | FREEDOM OXIMETER/EEG DIGITAL INTERFACE | Pro-Tech, Inc. | 1993-09-10 | Traditional | PDF ↗ |
| K920966 | SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) | Aristo Medical Products, Inc. | 1993-07-16 | Traditional | PDF ↗ |
| K915699 | NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 | Nellcor, Inc. | 1993-05-27 | Traditional | PDF ↗ |
| K924285 | MODEL 3500 MR-COMPATIBLE PULSE OXIMETER | Magnetic Resonance Equipment Corp. | 1993-05-11 | Traditional | PDF ↗ |
| K924282 | MODEL 320 MR-COMPATIBLE PULSE OXIMETER | Magnetic Resonance Equipment Corp. | 1993-05-07 | Traditional | PDF ↗ |
| K920066 | PALCO LABS MODEL 340 PULSE OXIMETER | Palco Laboratories, Inc. | 1993-03-16 | Traditional | PDF ↗ |
| K923418 | 9293/1 INTERFACE MODULE | S & W Medico Teknik | 1993-02-23 | Traditional | PDF ↗ |
Product code DQA · Class II · Cardiovascular. Data: openFDA.