FDA Product Code
FDA Product Code CCK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.1400
510(k) Clearances — 307 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K040011 | POLARIS 2004 CAPNOGRAPH | Oridion , Ltd. | 2004-05-13 | Special | PDF ↗ |
| K031741 | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 | Alaris Medical Systems, Inc. | 2004-02-09 | Traditional | PDF ↗ |
| K030886 | NICO WITH MARS, MODEL 7300 | Respironics Novametrix, Inc. | 2003-10-07 | Traditional | PDF ↗ |
| K030407 | ADVISOR, MODEL 9200 | Bci, Inc. | 2003-08-19 | Traditional | PDF ↗ |
| K031814 | STATCO2METER, MODEL 10-55372 | Mercury Medical | 2003-08-14 | Traditional | PDF ↗ |
| K031411 | MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 | Mercury Medical | 2003-07-30 | Traditional | PDF ↗ |
| K023820 | CO2 CLIP | Bregas AB | 2003-05-07 | Traditional | PDF ↗ |
| K023454 | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES | Datex-Ohmeda | 2003-04-23 | Abbreviated | PDF ↗ |
| K023579 | GAS SAMPLING LINES | Promedic, Inc. | 2003-01-28 | Traditional | PDF ↗ |
| K021576 | MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 | Mercury Medical | 2002-11-04 | Traditional | PDF ↗ |
| K020046 | MULTIGAS UNIT, MODEL AG-920RA | Nihon Kohden America, Inc. | 2002-07-25 | Traditional | PDF ↗ |
| K014211 | OXYARM CO2 | Southmedic, Inc. | 2002-06-11 | Traditional | PDF ↗ |
| K012139 | VAMOS ANESTHETIC GAS MONITOR | Draeger Medical, Inc. | 2002-01-17 | Abbreviated | PDF ↗ |
| K013845 | MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE | Oridion Medical 1987 , Ltd. | 2001-11-29 | Special | PDF ↗ |
| K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE | Oridion Medical 1987 , Ltd. | 2001-11-14 | Special | PDF ↗ |
| K012394 | ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE | Oridion Medical 1987 , Ltd. | 2001-08-15 | Special | PDF ↗ |
| K012391 | MAC-LINE CO2 NASAL CANNULA SAMPLE LINE | Oridion Medical 1987 , Ltd. | 2001-08-15 | Special | PDF ↗ |
| K012395 | MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE | Oridion Medical 1987 , Ltd. | 2001-08-15 | Special | PDF ↗ |
| K011050 | MICROSTREAM ORAL NASAL CANNULA FILTERLINE | Oridion Medical 1987 , Ltd. | 2001-05-04 | Special | PDF ↗ |
| K010795 | CAPNOPROBE SL, MODEL 2000 | Optical Sensors, Inc. | 2001-04-11 | Special | PDF ↗ |
| K010024 | O2/CO2 NASAL FILTERLINE | Oridion Medical 1987 , Ltd. | 2001-03-14 | Traditional | PDF ↗ |
| K003550 | INFINITY ETCO2 + RESPIRATORY MECHANICS POD | Siemens Medical Solutions USA, Inc. | 2001-03-07 | Traditional | PDF ↗ |
| K003982 | TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR | Magnetic Resonance Equipment Corp. | 2001-01-26 | Traditional | PDF ↗ |
| K002163 | MICROSTREAM EXTERNAL BATTERY CHARGER | Oridion Medical 1987 , Ltd. | 2001-01-11 | Traditional | PDF ↗ |
| K984579 | CAPNO PROBE A | Optical Sensors, Inc. | 2000-12-21 | Traditional | PDF ↗ |
| K001814 | DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES | Datex-Ohmeda | 2000-08-23 | Abbreviated | PDF ↗ |
| K000520 | C-IT | Bregas AB | 2000-05-16 | Traditional | PDF ↗ |
| K000712 | PORTABLE INTENSIVE CARE UNIT, MODEL PIC | Medical Research Laboratories, Inc. | 2000-04-27 | Special | PDF ↗ |
| K993656 | DATEX-OHMEDA TONOMETRY MODULE M-TONO | Datex-Ohmeda, Inc. | 2000-03-15 | Traditional | PDF ↗ |
| K992116 | SIEMEMNS INFINITY ETC02 POD | Siemens Medical Solutions USA, Inc. | 2000-01-12 | Traditional | PDF ↗ |
| K983864 | ETCO2 VITAL SIGNS MODULE | Mennen Medical, Inc. | 1999-10-08 | Traditional | PDF ↗ |
| K982969 | NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847 | Nonin Medical, Inc. | 1999-08-12 | Traditional | PDF ↗ |
| K991086 | CAPNOCHECK II, MODEL 8400 | Bci Intl., Inc. | 1999-06-09 | Traditional | PDF ↗ |
| K990063 | NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES | Nihon Kohden America, Inc. | 1999-06-09 | Traditional | PDF ↗ |
| K983114 | MAGNATEK80 | Magna Advanced Technologies, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K982846 | MTEK-1400 | Magna Advanced Technologies, Inc. | 1998-09-18 | Traditional | PDF ↗ |
| K981114 | MICROCAP | Oridion Medical , Ltd. | 1998-06-25 | Traditional | PDF ↗ |
| K980979 | FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE | Fukuda Denshi USA, Inc. | 1998-06-12 | Traditional | PDF ↗ |
| K973544 | VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER | Vacumed, Div. of Vacumetrics, Inc. | 1998-05-26 | Traditional | PDF ↗ |
| K980384 | TRIP TONOMETRY CATHETER, 18F | Datex-Engstrom, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K980325 | MICROSTREAM NASAL CANNULA FILTERLINE | Oridion Medical , Ltd. | 1998-04-16 | Traditional | PDF ↗ |
| K980327 | MICROSTREAM FILTERLINE ICU | Oridion Medical , Ltd. | 1998-04-16 | Traditional | PDF ↗ |
| K980324 | MICROSTREAM FILLERLINE OR/EMS | Oridion Medical , Ltd. | 1998-04-16 | Traditional | PDF ↗ |
| K973984 | RAC 2A MODULE HOUSING | Marquette Medical Systems, Inc. | 1998-01-16 | Traditional | PDF ↗ |
| K971229 | CAPNOXYGEN MASK | Medsys, Inc. | 1997-09-23 | Traditional | PDF ↗ |
| K964961 | MODEL 405T WITH ETCO2 OPTION | Ivy Biomedical Systems, Inc. | 1997-05-14 | Traditional | PDF ↗ |
| K964239 | COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER | Spegas Industries, Ltd. | 1997-05-09 | Traditional | PDF ↗ |
| K970209 | CAPNOCHECK PLUS | Bci Intl., Inc. | 1997-04-18 | Traditional | PDF ↗ |
| K962638 | TONOCAP, TC-200 AND ACCESSORY CATHETERS | Instrumentarium Corp. | 1997-04-04 | Traditional | PDF ↗ |
| K954120 | MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR | Magnetic Resonance Equipment Corp. | 1997-04-02 | Traditional | PDF ↗ |
| K964305 | NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES | Nihon Kohden America, Inc. | 1997-02-19 | Traditional | PDF ↗ |
| K963327 | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 | Novametrix Medical Systems, Inc. | 1996-11-20 | Traditional | PDF ↗ |
| K960972 | DISPOSABLE GAS SAMPLING INTERFACE KITS | Marquest Medical Products, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K961150 | DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA | Hudson Respiratory Care, Inc. | 1996-09-10 | Traditional | PDF ↗ |
| K954402 | ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | Icor AB | 1996-05-22 | Traditional | PDF ↗ |
| K954632 | SIEMENS SC 9000 ETCO2 MODULE | Siemens Medical Solutions USA, Inc. | 1996-02-05 | Traditional | PDF ↗ |
| K953006 | AS/3 NETWORK LINK | Datex Medical Instrumentation, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K950044 | FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE | Fukuda Denshi USA, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K952325 | ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | Icor AB | 1995-07-31 | Traditional | PDF ↗ |
| K944052 | RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR | Ohmeda Medical | 1995-07-07 | Traditional | PDF ↗ |
| K950387 | GEMINI | Spegas Industries, Ltd. | 1995-05-03 | Traditional | PDF ↗ |
| K950388 | POLARIS | Spegas Industries, Ltd. | 1995-05-02 | Traditional | PDF ↗ |
| K950581 | SMART ANESTHESIA MULTI-GAS (SAM) MODULE | Marquette Electronics, Inc. | 1995-03-29 | Traditional | PDF ↗ |
| K951127 | HEWLETT-PACKARD MODEL M1026A ANESTHETIC GAS MODULE | Hewlett-Packard GmbH | 1995-03-24 | Traditional | PDF ↗ |
| K943977 | SMART ANESTHESIA MULTI-GAS (SAM) MODULE | Marquette Electronics, Inc. | 1995-03-23 | Traditional | PDF ↗ |
| K943389 | SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM | Hewlett-Packard Co. | 1995-03-17 | Traditional | PDF ↗ |
| K944541 | HANDYPACK 911SC | Pace Tech, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K942849 | CAPNOSAT | Spegas Industries, Ltd. | 1995-02-21 | Traditional | PDF ↗ |
| K942113 | CARBON DIOXIDE ANALYZER (MODEL CD-3A) | Ametek, Inc. | 1995-02-16 | Traditional | PDF ↗ |
| K946044 | DISPOSABLE GAS SAMPLING LINES | Catheter Research, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K941971 | 9100 MUTIGAS MONITOR | Bci Intl., Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K941982 | CAPNOCHECK | Bci, Inc. | 1994-10-17 | Traditional | PDF ↗ |
| K941165 | COMET CAPNOGRAPH MODULE | Spacelabs, Inc. | 1994-10-06 | Traditional | PDF ↗ |
| K944400 | PEDI-CAP | Nellcor, Inc. | 1994-09-27 | Traditional | PDF ↗ |
| K925701 | MINIPACK 911-STC | Pace Tech, Inc. | 1994-08-11 | Traditional | PDF ↗ |
| K935477 | AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD | Datex Division Instrumentarium Corp. | 1994-08-01 | Traditional | PDF ↗ |
| K942772 | A-200 MULTI-USE AIRWAY ADAPTER | Pryon Corp. | 1994-07-25 | Traditional | PDF ↗ |
| K935272 | CAP 400 AT | Pryon Corp. | 1994-07-13 | Traditional | PDF ↗ |
| K933284 | AS/3 TM NETWORK | Datex Division Instrumentarium Corp. | 1994-07-11 | Traditional | PDF ↗ |
| K942567 | MASS SPECTROMETRY MONITORING LINES AND CONNECTORS | Med-Plastics Intl., Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K930524 | END TIDAL CO2 OPTION B | Medical Data Electronics | 1994-02-07 | Traditional | PDF ↗ |
| K933707 | CAPNODIG | Spegas Industries, Ltd. | 1993-10-27 | Traditional | PDF ↗ |
| K930250 | LOW DEAD SPACE ADAPTOR & REUASABLE AIRWAY ADAPTOR | Pryon Corp. | 1993-10-15 | Traditional | PDF ↗ |
| K933980 | HP M1465A STANDARD AIRWAY ADAPTER | Hewlett-Packard Co. | 1993-09-09 | Traditional | PDF ↗ |
| K930559 | VITALMAX 800-C | Pace Tech, Inc. | 1993-09-03 | Traditional | PDF ↗ |
| K915494 | NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60 | Nellcor, Inc. | 1993-08-06 | Traditional | PDF ↗ |
| K930957 | ZEFON GAS SAMPLING LINES | Zefon Medical Products | 1993-07-02 | Traditional | PDF ↗ |
| K925484 | CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 | Bruel & Kjaer | 1993-06-22 | Traditional | PDF ↗ |
| K930866 | RASCAL II | Ohmeda Medical | 1993-05-13 | Traditional | PDF ↗ |
| K925424 | MEDICAL MANUFACTURING INC GAS SAMPLING LINES&CONN. | Medical Manufacturers, Inc. | 1993-04-19 | Traditional | PDF ↗ |
| K920915 | CAPNOMED 100 STAND-ALONE ETCO2 MODULE | Mennen Medical, Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K921497 | PROPAQ MONITORS, MODIFICATION | Protocol Systems, Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K924083 | 700/700-1 | Citicare Systems, Inc. | 1993-03-10 | Traditional | PDF ↗ |
| K925167 | MASS SPECTROMETRY MONITORING LINE CONONECTORS | Merit Medical Systems, Inc. | 1993-01-22 | Traditional | PDF ↗ |
| K923305 | BATTERY PACKS | Access / God Loves You | 1992-12-17 | Traditional | PDF ↗ |
| K913995 | VITALERT 3000 MONITORING SYSTEM | Draeger Medical, Inc. | 1992-11-03 | Traditional | PDF ↗ |
| K921526 | DATASCOPE PASSPORT MONITOR WITH CO2 | Datascope Corp. | 1992-10-14 | Traditional | PDF ↗ |
| K920622 | RASCAL II | Ohmeda Medical | 1992-10-13 | Traditional | PDF ↗ |
| K920590 | OHMEDA MODEL 5250 RGM MONITOR | Ohmeda Medical | 1992-08-31 | Traditional | PDF ↗ |
| K911970 | NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE | Nasorcap Ent., Inc. | 1992-08-14 | Traditional | PDF ↗ |
Product code CCK · Class II · Anesthesiology. Data: openFDA.