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 7 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K925542 | OXYSHUTTLE II ,MODIFICATION | Sensor Medics Corp. | 1993-02-17 | Traditional | PDF ↗ |
| K923343 | HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER | Hewlett-Packard Co. | 1993-02-10 | Traditional | PDF ↗ |
| K920082 | BIOCHEM MODEL 3301 NEWOX1 OXIMETER | Biochem International, Inc. | 1993-01-07 | Traditional | PDF ↗ |
| K910811 | SENSOR SHIELD | Medical Taping Systems, Inc. | 1992-12-23 | Traditional | PDF ↗ |
| K922075 | AVOXIMETER | A-Vox Systems, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K921519 | OXICOM-2100 | Waters Instruments, Inc. | 1992-10-23 | Traditional | PDF ↗ |
| K923682 | MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE | Hewlett-Packard Co. | 1992-09-28 | Traditional | PDF ↗ |
| K920379 | NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX | Novametrix Medical Systems, Inc. | 1992-07-15 | Traditional | PDF ↗ |
| K914538 | UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER | Innovative Medical Products, Inc. | 1992-07-14 | Traditional | PDF ↗ |
| K915773 | P-300 CAPNOGRAPH AND PULSE OXIMETER | Pryon Corp. | 1992-06-24 | Traditional | PDF ↗ |
| K910077 | CRIT-SCAN | Noninvasive Medical Technology Corp. | 1992-06-02 | Traditional | PDF ↗ |
| K914620 | HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION | Vitalog Monitoring,Inc. | 1992-05-01 | Traditional | PDF ↗ |
| K913790 | SENSORMEDICS OXYSHUTTLE II(TM) | Sensor Medics Corp. | 1992-02-26 | Traditional | PDF ↗ |
| K912880 | VITALMAX 510/520 | Pace Tech, Inc. | 1991-11-14 | Traditional | PDF ↗ |
| K913695 | NELLCOR(R) N-180 PULSE OXIMETER | Nellcor, Inc. | 1991-11-13 | Traditional | PDF ↗ |
| K913516 | MODEL 520A NOVAMETRIX PULSE OXIMETER | Novametrix Medical Systems, Inc. | 1991-11-04 | Traditional | PDF ↗ |
| K911761 | SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION | S & W Medico Teknik | 1991-10-31 | Traditional | PDF ↗ |
| K913489 | SIEMENS MICRO2 PULSE OXIMETER | Siemens Medical Electronics | 1991-10-30 | Traditional | PDF ↗ |
| K913332 | CIBA CORNING MODEL 270 CO-OXIMETER | Ciba Corning Diagnostics Corp. | 1991-10-23 | Traditional | PDF ↗ |
| K911207 | OXICOMPLUS | Waters Instruments, Inc. | 1991-08-26 | Traditional | PDF ↗ |
| K910001 | MODEL 8604-FO PULSE OXIMETER | Nonin Medical, Inc. | 1991-07-18 | Traditional | PDF ↗ |
| K911191 | PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR | Palco Laboratories, Inc. | 1991-06-10 | Traditional | PDF ↗ |
| K911124 | 503 PULSE OXIMETER | Criticare Systems, Inc. | 1991-06-07 | Traditional | PDF ↗ |
| K905310 | MINIOX V PULSE OXIMETER | Catalyst Research Corp. | 1991-05-28 | Traditional | PDF ↗ |
| K905140 | SATLITE PLUS PULSE OXIMETER | Datex Division Instrumentarium Corp. | 1991-05-28 | Traditional | PDF ↗ |
| K910629 | AP-860PA NIBP MODULE | Nihon Kohden America, Inc. | 1991-05-14 | Traditional | PDF ↗ |
| K910770 | 504US PULSE OXIMETER | Criticare Systems, Inc. | 1991-05-14 | Traditional | PDF ↗ |
| K910521 | SYSTEM 7300 PULSE OXIMETER | Advanced Medical Instruments, Inc. | 1991-04-18 | Traditional | PDF ↗ |
| K904988 | PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR | Palco Laboratories, Inc. | 1991-03-18 | Traditional | PDF ↗ |
| K904088 | ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC | Sentinel | 1991-02-05 | Traditional | PDF ↗ |
| K904039 | REFLECTANCE SENSOR (RS-10) | Nellcor, Inc. | 1990-12-27 | Traditional | PDF ↗ |
| K900001 | COROMETRICS MODEL 556 NEONATAL MONITOR | Ge Medical Systems Information Technologies | 1990-11-29 | Traditional | PDF ↗ |
| K903523 | HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE | Hewlett-Packard Co. | 1990-10-23 | Traditional | PDF ↗ |
| K902730 | SPO2 OPTION | Protocol Systems, Inc. | 1990-10-22 | Traditional | PDF ↗ |
| K903702 | MODEL 90421 FLEXPORT INTERFACE | Spacelabs, Inc. | 1990-10-19 | Traditional | PDF ↗ |
| K902779 | MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA | S & W Medico Teknik | 1990-09-27 | Traditional | PDF ↗ |
| K901066 | VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA. | Pace Tech, Inc. | 1990-08-28 | Traditional | PDF ↗ |
| K901504 | MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP. | Ivy Biomedical Systems, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K902192 | MODEL MSC SA02-5000 PULSE OXIMETER | Medical Systems Corp. | 1990-08-23 | Traditional | PDF ↗ |
| K902758 | COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC | Cobe Laboratories, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K900757 | ITC ANGIOGRAPHIC CATHETER | Interventional Therapeutics Corp. | 1990-08-14 | Traditional | PDF ↗ |
| K896738 | TYPE 9293 INTERFACE PULSEOX | S & W Medico Teknik | 1990-08-14 | Traditional | PDF ↗ |
| K901819 | MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) | Hewlett-Packard Co. | 1990-07-18 | Traditional | PDF ↗ |
| K901071 | PULSE OXIMETRY MODULE | Marquette Electronics, Inc. | 1990-06-19 | Traditional | PDF ↗ |
| K901399 | POWERBASE II (PB2) | Nellcor, Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K902060 | ESCORT MODEL 300 | Medical Data Electronics | 1990-06-11 | Traditional | PDF ↗ |
| K901774 | HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL | Mennen Medical, Inc. | 1990-05-22 | Traditional | PDF ↗ |
| K892217 | CAV SAT OXIMETER MODEL 100 | Somanetics Corp. | 1990-05-18 | Traditional | PDF ↗ |
| K901060 | EDENTEC MODEL 2000W SYSTEM 700 MONITOR | Edentec Corp. | 1990-05-15 | Traditional | PDF ↗ |
| K894100 | OXYTRAK(TM) PULSE OXIMETER | Critikon Company, LLC | 1990-05-09 | Traditional | PDF ↗ |
| K901612 | VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE | Pace Tech, Inc. | 1990-04-30 | Traditional | PDF ↗ |
| K901209 | MODEL 90489 PULSE OXIMETER MODULE | Spacelabs, Inc. | 1990-04-30 | Traditional | PDF ↗ |
| K900866 | OXIMAX 700 | Pace Tech, Inc. | 1990-04-04 | Traditional | PDF ↗ |
| K900843 | OXIMAX 100 | Pace Tech, Inc. | 1990-03-28 | Traditional | PDF ↗ |
| K893221 | MODEL 8500 HAND HELD PULSE OXIMETER | Nonin Medical, Inc. | 1990-02-28 | Traditional | PDF ↗ |
| K895987 | KELLER PULSE OXIMETER - KMS 850 | Keller Medical Specialties Products, Inc. | 1990-02-22 | Traditional | PDF ↗ |
| K893643 | NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER | Novametrix Medical Systems, Inc. | 1989-10-26 | Traditional | PDF ↗ |
| K892120 | ESCORT PULSE OXIMETRY OPTION | Medical Data Electronics | 1989-09-26 | Traditional | PDF ↗ |
| K895425 | MINIMON 7137B PATIENT MONITOR | Kontron Instruments, Inc. | 1989-09-26 | Traditional | PDF ↗ |
| K893867 | CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE | Spacelabs, Inc. | 1989-09-13 | Traditional | PDF ↗ |
| K893587 | OXIMETER | Radiometer America, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K893470 | SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE | Siemens Medical Electronics | 1989-08-03 | Traditional | PDF ↗ |
| K884121 | TYPE 9266 SAO2 SYSTEM ATHENA | S & W Medico Teknik | 1989-04-25 | Traditional | PDF ↗ |
| K890753 | SATLITE TRANS PORTABLE PULSE OXIMETER | Datex Division Instrumentarium Corp. | 1989-03-22 | Traditional | PDF ↗ |
| K884822 | MODEL OX-1 OXYGEN SATURATION MODULE | Colin Medical Instruments Corp. | 1989-03-02 | Traditional | PDF ↗ |
| K890299 | KONTRON PULSE OXIMETER 7840 | Kontron Instruments, Inc. | 1989-03-02 | Traditional | PDF ↗ |
| K884050 | CNS-8200A CENTRAL NURSES STATION | Nihon Kohden America, Inc. | 1989-02-23 | Traditional | PDF ↗ |
| K890033 | MODEL 8700 PULSE OXIMETER | Nonin Medical, Inc. | 1989-02-06 | Traditional | PDF ↗ |
| K884536 | AL-800PA PULSE OXIMETER MODULE | Nihon Kohden America, Inc. | 1989-02-06 | Traditional | PDF ↗ |
| K884614 | EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. | Edentec Corp. | 1989-02-01 | Traditional | PDF ↗ |
| K884891 | OC-100 OXIMETER INTERFACE CALIBRATOR | Telediagnostic Systems, Inc. | 1988-12-28 | Traditional | PDF ↗ |
| K884329 | SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER | Baxter Healthcare Corp | 1988-12-16 | Traditional | PDF ↗ |
| K881307 | OLV 1100; OLV 1200 PULSE OXIMETERS | Nihon Kohden America, Inc. | 1988-11-04 | Traditional | PDF ↗ |
| K883877 | BM-103 BATTERY MODULE | Datex Division Instrumentarium Corp. | 1988-10-28 | Traditional | PDF ↗ |
| K873624 | KONTRON PULSE OXIMETER 7840 | Kontron Instruments, Inc. | 1988-10-19 | Traditional | PDF ↗ |
| K883297 | HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER | Hewlett-Packard Co. | 1988-10-06 | Traditional | PDF ↗ |
| K880756 | MODEL PM-20A PHYSIOLOGICAL MONITOR | Advanced Medical Systems, Inc. | 1988-09-27 | Traditional | PDF ↗ |
| K882664 | MRL OXIMETER | Medical Research Laboratories, Inc. | 1988-09-16 | Traditional | PDF ↗ |
| K882273 | HORIZON 2000 PULSE OXIMETRY AND MODULE | Mennen Medical, Inc. | 1988-08-25 | Traditional | PDF ↗ |
| K881820 | EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER | Edentec Corp. | 1988-07-18 | Traditional | PDF ↗ |
| K881883 | SATLITE+/PB251+ PULSE OXIMETER | Datex Division Instrumentarium Corp. | 1988-07-18 | Traditional | PDF ↗ |
| K881136 | HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI. | Hewlett-Packard Co. | 1988-05-18 | Traditional | PDF ↗ |
| K880672 | SENTINEL PULSE OXIMETER | Sentinel Monitoring Technologies, Ltd. | 1988-05-06 | Traditional | PDF ↗ |
| K872520 | SS-1000 POLYGRAPH | Meramed Corp. | 1988-04-19 | Traditional | PDF ↗ |
| K874198 | VITALOG HMS-3000 | Vitalog Corp. | 1988-03-22 | Traditional | PDF ↗ |
| K874492 | LAWRENCE L4000 REFLECTANCE PULSE OXIMETER | Lawrence Medical Systems, Inc. | 1988-03-22 | Traditional | PDF ↗ |
| K873896 | SIMED S-100 PULSE OXIMETER | Simed | 1988-03-07 | Traditional | PDF ↗ |
| K875298 | 502-US PULSE OXIMETER | Criticare Systems, Inc. | 1988-03-07 | Traditional | PDF ↗ |
| K874442 | DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER | Critikon Company, LLC | 1988-02-18 | Traditional | PDF ↗ |
| K874947 | MODEL 8800 CARDIORESPIRATORY OXIMETER | Nonin Medical, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K875031 | OXYGEN/PULSE MONITOR | Healthdyne, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K874692 | PULSEMATE BX-5 | Colin Medical Instruments Corp. | 1988-02-02 | Traditional | PDF ↗ |
| K873199 | OHMEDA 4700 OXICAP MONITOR | Ohmeda Medical | 1988-02-02 | Traditional | PDF ↗ |
| K874132 | MINIOX IV PORTABLE PULSE OXIMETER | Catalyst Research Corp. | 1988-01-19 | Traditional | PDF ↗ |
| K873859 | CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104 | Datex Division Instrumentarium Corp. | 1987-12-29 | Traditional | PDF ↗ |
| K874104 | OHMEDA BIOX 3760 PULSE OXIMETER | Ohmeda Medical | 1987-12-03 | Traditional | PDF ↗ |
| K873081 | EDENTEC MULTI-CHANNEL RECORDER | Edentec Corp. | 1987-11-17 | Traditional | PDF ↗ |
| K873065 | MODEL 7200A WITH PULSE OXIMETRY | Puritan Bennett Corp. | 1987-10-26 | Traditional | PDF ↗ |
| K863857 | PULSE-OX | Life Design Systems, Inc. | 1987-10-07 | Traditional | PDF ↗ |
| K872772 | OHMEDA BIOX 3740 PULSE OXIMETER | Ohmeda Medical | 1987-10-07 | Traditional | PDF ↗ |
Product code DQA · Class II · Cardiovascular. Data: openFDA.