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 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K914337 | GAS SAMPLING INTERFACES | Vital Signs, Inc. | 1992-03-11 | Traditional | PDF ↗ |
| K915228 | DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL | Hospitak, Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K911193 | OHMEDA MODEL 4700 OXICAP | Ohmeda Medical | 1991-08-02 | Traditional | PDF ↗ |
| K911737 | MEDICAL ASSEMBLIES MASS SPECT MONIT LINE/CONNECT | Medical Assemblies, Inc. | 1991-07-11 | Traditional | PDF ↗ |
| K904863 | MGA-IR SIDESTREAM PCO2 MODULE | Marquette Gas Analysis Corp. | 1991-06-19 | Traditional | PDF ↗ |
| K904789 | SERIES 7000 CARBON DIOXIDE MODULE | Marquette Electronics, Inc. | 1991-05-22 | Traditional | PDF ↗ |
| K910509 | PATIENT GAS SAMPLING LINE FOR OHMEDA 6000 | Intertech Resources, Inc. | 1991-04-17 | Traditional | PDF ↗ |
| K910106 | DATASCOPE MULTINEX ID MONITOR | Datascope Corp. | 1991-03-29 | Traditional | PDF ↗ |
| K910019 | NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON | Novametrix Medical Systems, Inc. | 1991-03-26 | Traditional | PDF ↗ |
| K905775 | SIEMENS ETCO2 CARTRIDGE | Siemens Medical Electronics | 1991-03-11 | Traditional | PDF ↗ |
| K903200 | MINICAP III CO2 DETECTOR | Minesafety Appliances Co. | 1990-09-21 | Traditional | PDF ↗ |
| K896652 | CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | 1990-09-05 | Traditional | PDF ↗ |
| K901861 | BIOCHEM 9100 MULTIGAS MONITOR | Biochem International, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901132 | SARA SATCAP | Ppg Industries, Inc. | 1990-05-22 | Traditional | PDF ↗ |
| K900291 | MASS SPECTROMETRY MONITORING LINES AND CONNECTORS | F.L.W. Plastics, Inc. | 1990-03-28 | Traditional | PDF ↗ |
| K900979 | GAS SAMPLING NASAL CANNULA | Gibeck, Inc. | 1990-03-16 | Traditional | PDF ↗ |
| K896737 | TYPE 9292 INTERFACE CAPNOGRAPH | S & W Medico Teknik | 1990-02-28 | Traditional | PDF ↗ |
| K895001 | TYPE EXPIRED CO2 9270, CAPNOGRAPH | S & W Medico Teknik | 1990-02-22 | Traditional | PDF ↗ |
| K894691 | MODEL AO-800PA CO2 MODULE | Nihon Kohden America, Inc. | 1989-12-22 | Traditional | PDF ↗ |
| K896030 | HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02 | Hewlett-Packard Co. | 1989-12-22 | Traditional | PDF ↗ |
| K895780 | OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER | Datex Division Instrumentarium Corp. | 1989-11-29 | Traditional | PDF ↗ |
| K894350 | SALTER LABS MODEL #4009 SAMPLE LINES | Salter Labs | 1989-10-03 | Traditional | PDF ↗ |
| K894429 | MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR | Fenem, Inc. | 1989-09-18 | Traditional | PDF ↗ |
| K890817 | OMNI-TRAK (PATIENT MONITOR) | Invivo Research, Inc. | 1989-08-10 | Traditional | PDF ↗ |
| K891076 | CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR | Datex Division Instrumentarium Corp. | 1989-08-02 | Traditional | PDF ↗ |
| K893589 | MULTI-GAS ANALYZER (MGA) | Marquette Gas Analysis Corp. | 1989-07-27 | Traditional | PDF ↗ |
| K892406 | MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA | Salter Labs | 1989-07-24 | Traditional | PDF ↗ |
| K894053 | 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR | Fenem, Inc. | 1989-07-20 | Traditional | PDF ↗ |
| K890874 | BIOCHEM 520 BREATH INDICATOR | Biochem International, Inc. | 1989-06-15 | Traditional | PDF ↗ |
| K890112 | ENGSTROM ELIZA + CO2 ANALYZER | Gambro, Inc. | 1989-03-15 | Traditional | PDF ↗ |
| K883090 | MINICAP TM 100 CAPNOMETER | Minesafety Appliances Co. | 1989-01-30 | Traditional | PDF ↗ |
| K884158 | THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER | Ppg Industries, Inc. | 1989-01-17 | Traditional | PDF ↗ |
| K881206 | CHRONAMED CM101 | Chronamed Corp. | 1988-12-05 | Traditional | PDF ↗ |
| K884080 | MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR | Fenem, Inc. | 1988-10-21 | Traditional | PDF ↗ |
| K882885 | DATEX AIRWAY MONITOR | Datex Division Instrumentarium Corp. | 1988-10-19 | Traditional | PDF ↗ |
| K882748 | NORMOCAP 200 CAPNOMETER | Datex Division Instrumentarium Corp. | 1988-10-19 | Traditional | PDF ↗ |
| K883950 | MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER | Fenem, Inc. | 1988-09-29 | Traditional | PDF ↗ |
| K883821 | FEF(TM) END-TIDAL CO2 DETECTOR | Fenem, Inc. | 1988-09-26 | Traditional | PDF ↗ |
| K882661 | ACUMED 9000 ETCO(2) MONITOR | Acumed Technologies, Inc. | 1988-08-24 | Traditional | PDF ↗ |
| K881002 | O.R. SARACAP | Ppg/Applied Resources, Inc. | 1988-08-15 | Traditional | PDF ↗ |
| K881093 | ICU SARACAP | Ppg/Applied Resources, Inc. | 1988-06-24 | Traditional | PDF ↗ |
| K882172 | SARACAP AG | Ppg/Applied Resources, Inc. | 1988-06-24 | Traditional | PDF ↗ |
| K873396 | KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281 | Kontron Instruments, Inc. | 1988-06-21 | Traditional | PDF ↗ |
| K873380 | VITALERT 1000 MONITORING SYSTEM | Draeger Medical, Inc. | 1988-04-14 | Traditional | PDF ↗ |
| K874724 | SARA AGIE MONITOR | Ppg/Applied Resources, Inc. | 1988-03-29 | Traditional | PDF ↗ |
| K874754 | SARA DIGICAP | Ppg/Applied Resources, Inc. | 1988-03-21 | Traditional | PDF ↗ |
| K871828 | TED MODEL 760 | Teledyne, Inc. | 1988-02-04 | Traditional | PDF ↗ |
| K875268 | TMM MODEL 2500 CAPMONITOR | Traverse Medical Monitors | 1988-01-22 | Traditional | PDF ↗ |
| K873856 | BIOCHEM 9090 CAPNOGRAPH/SAO2 | Biochem International, Inc. | 1987-12-17 | Traditional | PDF ↗ |
| K873959 | BIOCHEM 8800 CAPNOMETER | Biochem International, Inc. | 1987-12-11 | Traditional | PDF ↗ |
| K874036 | MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY | Novametrix Medical Systems, Inc. | 1987-11-06 | Traditional | PDF ↗ |
| K873149 | NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260 | Novametrix Medical Systems, Inc. | 1987-11-06 | Traditional | PDF ↗ |
| K872760 | OSCAR(TM) PB255 OXIMETER CAPNOMETER | Datex Division Instrumentarium Corp. | 1987-09-14 | Traditional | PDF ↗ |
| K871253 | MASSTRON/MARQUEST MT-1000 GAS ANALYZER | Masstron C/O Burditt, Bowles & Radzius, Ltd. | 1987-06-15 | Traditional | PDF ↗ |
| K870858 | BADGWELL SAMPLING CATHETER | Dryden Corp. | 1987-05-14 | Traditional | PDF ↗ |
| K871133 | BIOCHEM 8090 CAPNOGRAPH | Biochem International, Inc. | 1987-04-21 | Traditional | PDF ↗ |
| K864199 | SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA | Salter Labs | 1987-02-10 | Traditional | PDF ↗ |
| K864903 | MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULA | Salter Labs | 1987-01-30 | Traditional | PDF ↗ |
| K864902 | MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU. | Salter Labs | 1987-01-28 | Traditional | PDF ↗ |
| K863883 | MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA | Salter Labs | 1986-10-27 | Traditional | PDF ↗ |
| K863703 | SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE | Salter Labs | 1986-10-15 | Traditional | PDF ↗ |
| K863640 | MODIFIED GAS SAMPLING KIT | Respiratory Support Products, Inc. | 1986-10-08 | Traditional | PDF ↗ |
| K862880 | SARA RT | Alleghany Intl. Medical Technology | 1986-08-25 | Traditional | PDF ↗ |
| K862605 | MODULAR MASS SPECTROMETER (M.S.) | The Perkin-Elmer Corp. | 1986-08-13 | Traditional | PDF ↗ |
| K862559 | CARBOSTAT, CO2 ANALYZER | Elm Street Designs | 1986-07-15 | Traditional | PDF ↗ |
| K862543 | DYNEX CO2/2000, CO2 ANALYZER | Analytical Products, Inc. | 1986-07-15 | Traditional | PDF ↗ |
| K861398 | PRE-CHECK C02 DETECTOR | Alleghany Intl. Medical Technology | 1986-05-06 | Traditional | PDF ↗ |
| K861213 | PB 254 IR - SPECTROMETER | Datex Division Instrumentarium Corp. | 1986-04-04 | Traditional | PDF ↗ |
| K860556 | SERIES 7050 CAPNOGRAPH | Marquette Electronics, Inc. | 1986-02-21 | Traditional | PDF ↗ |
| K853396 | MULTICAP MULTIGAS CAPNOMETER PB252 | Instrumentarium Corp. | 1985-08-16 | Traditional | PDF ↗ |
| K852062 | SARACAP RESPIRATORY MONITOR | Alleghany Intl. Medical Technology | 1985-08-06 | Traditional | PDF ↗ |
| K852463 | ANDROS ANALYZERS AIRWAY ADAPTER | Andros Analyzers, Inc. | 1985-07-08 | Traditional | PDF ↗ |
| K851658 | CAPNOMED | Draeger Medical, Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K851001 | SERIES 7000 END TIDAL CO2 MONITORING SYSTEM | Marquette Electronics, Inc. | 1985-05-13 | Traditional | PDF ↗ |
| K850745 | TRI-MED MODEL 112 MOISTURE TRAP | Tri-Med, Inc. | 1985-04-02 | Traditional | PDF ↗ |
| K850747 | TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR | Tri-Med, Inc. | 1985-04-02 | Traditional | PDF ↗ |
| K850746 | TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI | Tri-Med, Inc. | 1985-04-02 | Traditional | PDF ↗ |
| K844010 | CPNOGARD CAPNOMETER 1250 | Novametrix Medical Systems, Inc. | 1985-02-21 | Traditional | PDF ↗ |
| K843285 | TRI-MED 610 CAPNOSTAT GAS ANALYZER | Tri-Med, Inc. | 1984-11-13 | Traditional | PDF ↗ |
| K843970 | MODEL IM1074 END-TIDAL CO2 MODULE | Gould, Inc. | 1984-10-24 | Traditional | PDF ↗ |
| K843844 | CO2 TEST | Erich Jaeger, Inc. | 1984-10-12 | Traditional | PDF ↗ |
| K843599 | OHMEDA MODEL 5200 CO2 MONITOR | Ohmeda Medical | 1984-10-04 | Traditional | PDF ↗ |
| K842334 | LIFE MONITOR I | St. Croix Medical Systems, Inc. | 1984-08-30 | Traditional | PDF ↗ |
| K842978 | 540 CAPNOGRAPH | Spacelabs, Inc. | 1984-08-24 | Traditional | PDF ↗ |
| K842325 | CAPNOMETER | Sensors, Inc. | 1984-06-26 | Traditional | PDF ↗ |
| K841498 | C02 MONITOR-OIR-7101 | Nihon Kohden America, Inc. | 1984-05-14 | Traditional | PDF ↗ |
| K840966 | ANESTHETIC GAS MONITOR SYS | Marquest Medical Products, Inc. | 1984-05-14 | Traditional | PDF ↗ |
| K832005 | JP-2 RESPIRATORY MONITORING SYSTEM | Morgan Associates, Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K833397 | TRI-MED 511 INFANT RESPIRATION MONITOR | Tri-Med, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K831447 | CAPNOMETER W/NEW AIRWAY ADAPTER 47210A | Hewlett-Packard Co. | 1983-11-21 | Traditional | PDF ↗ |
| K833060 | MODEL CD-3A-INCLUDING P-61B SENSOR | Applied Electrochemistry, Inc. | 1983-11-03 | Traditional | PDF ↗ |
| K832767 | ADVANTAGE #1700 | The Perkin-Elmer Corp. | 1983-11-03 | Traditional | PDF ↗ |
| K831776 | CAPNOGRAPH | Datascope Corp. | 1983-10-31 | Traditional | PDF ↗ |
| K823049 | ENGSTROM ELIZA CO2 ANALYZER | Lkb Instruments, Inc. | 1983-01-12 | Traditional | PDF ↗ |
| K812643 | LIFESPAN CO2 | Biochem International, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K810927 | RESPIRATORY INTENSIVE CARE SYSTEM (RICS) | Allied Healthcare Products, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K802459 | SIEMENS-ELEMA AB CO2 MONITOR 130 | Siemens Elema AB | 1980-10-23 | Traditional | PDF ↗ |
| K800869 | MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA | Cavitron Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K792155 | CO 2 METER | Boehringer Laboratories | 1979-11-27 | Traditional | PDF ↗ |
| K791570 | IL MODEL END TIDAL CO2 ANALYZER | Instrumentation Laboratory CO | 1979-09-04 | Traditional | PDF ↗ |
Product code CCK · Class II · Anesthesiology. Data: openFDA.