FDA 510(k) Applications for Medical Device Product Code "CCL"
(Analyzer, Gas, Oxygen, Gaseous-Phase)

FDA 510(k) Number Applicant Device Name Decision Date
K944654 AEQUITRON MEDICAL, INC. OXYGEN CONCENTRATION INDICATOR 11/08/1994
K830446 AIRCO/OHIO MEDICAL PRODUCTS OXYGEN MONITOR OHIO 5100 03/24/1983
K943824 AMETEK, INC. GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION 11/01/1996
K875183 AMETEK/THERMOX INSTRUMENTS DIVISION LC OXYGEN ANALYZER 03/29/1988
K002382 ANALYTICAL INDUSTRIES, INC. 'ALL 2000' % OXYGEN ANALYZER 03/14/2001
K053407 ANALYTICAL INDUSTRIES, INC. OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M 04/05/2006
K952736 ANALYTICAL INDUSTRIES, INC. PERCENT OXYGEN SENSOR 10/18/1995
K871337 BIO-MED DEVICES, INC. M-2 OXYGEN/TEMPERATURE MONITOR 06/05/1987
K831522 BIO-TEK INSTRUMENTS, INC. BIO-TEK PERCENT OXYGEN MONITOR 74222 09/12/1983
K910381 BIOCHEM INTERNATIONAL, INC. BIOCHEM TEMPERATURE/ FIO2 MODULE 08/22/1991
K023565 CARADYNE, LTD. OXICHECK 03/28/2003
K782062 CATALYST RESEARCH CORP. ANALYZER, OXYGEN MODEL M25RA & M25RAD 02/15/1979
K833995 CATALYST RESEARCH CORP. MINI OX II 12/12/1983
K790784 CATALYST RESEARCH CORP. MODEL M25R, OXYGEN ANALYZER 04/27/1979
K790785 CATALYST RESEARCH CORP. MODEL M25RL, (CRC) OXYGEN ANALYZER 04/27/1979
K771028 CAVITRON CORP. ANALYZER, OXYGEN, MODEL OM-92 07/05/1977
K972992 CERAMATEC, INC. CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS 03/30/1998
K911344 CERAMATEC, INC. CERION HAND HELD OXYGEN ANALYZER 06/18/1991
K880448 CERAMATEC, INC. CERION OXY THRESHOLD ALARM 03/21/1988
K973282 CERAMATEC, INC. HANDI OXYGEN ANALYZER 03/04/1998
K863158 CHRYSALIS SYSTEMS, INC. MODEL T-1 OXYGEN ANALYZER 11/13/1986
K041773 CITY TECHNOLOGY LIMITED OXYGEN MEDICELS, CITICELS 07/15/2004
K882352 CLINICAL INFORMATION SYSTEMS, INC. MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT. 11/02/1988
K944120 CORE-M, L.P. FI02 SENSING MODULE 05/10/1995
K782114 CRITIKON COMPANY,LLC MONITOR, OXYCHEK OXYGEN 01/18/1979
K883254 DATASCOPE CORP. MULTINEX MONITOR (MODIFICATION) 09/12/1988
K913392 DEVILBISS HEALTH CARE, INC. OXYGEN SENSING DEVICE, MODIFICATION 07/17/1992
K072469 DIGIFLO, INC. DIGIFLO CONCENTRATOR ANALYZER 01/03/2008
K831238 DRAEGER MEDICAL, INC. OXYMED 05/09/1983
K082655 ENVITEC-WISMAR GMBH ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 11/25/2008
K122290 ENVITEC-WISMAR GMBH ENVITEC MYSIGN O OXYGEN MEASURING DEVICE 01/23/2013
K843847 ERICH JAEGER, INC. O2 TEST 10/12/1984
K852823 FERGUSON MEDICAL DMA OXYGEN MONITOR 10/29/1985
K813198 FLORIDA MEDICAL EQUIPMENT REPAIR, INC. RESPIRATOR MONITOR 12/08/1981
K840645 GAMBRO, INC. ENGSTROM ELIZA DUO CO2 & O2 ANALYZ 04/05/1984
K051092 GE HEALTHCARE DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC 05/25/2005
K123195 GE HEALTHCARE FINLAND OY CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES 02/28/2013
K982619 HEWLETT-PACKARD CO. HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 08/12/1998
K770207 HEWLETT-PACKARD CO. MONITOR, OXYGEN, MODEL 78216C 02/17/1977
K830124 HEWLETT-PACKARD CO. OPTION A02 MODEL 15202A 02/09/1983
K840565 HUDSON OXYGEN THERAPY SALES CO. MONITOR 5590- ANALYZER 5595EC 04/02/1984
K801083 INSTRUMENTARIUM-DATEX NORMCAP CD-102, CARBON DIOXIDE ANALYZER 05/28/1980
K802762 INSTRUMENTARIUM-DATEX NORMOCAP CR-102, RECORDER UNIT 11/26/1980
K822608 INSTRUMENTATION INDUSTRIES, INC. MK 808 SERIES NASAL OXYGEN SAMPLER 10/04/1982
K823374 INSTRUMENTATION LABORATORY CO. OXYGEN MONITOR IL 408 12/09/1982
K002384 INTERNATIONAL BUSINESS STRATEGIES M-XX OXYGEN SENSORS 12/15/2000
K984295 INVACARE CORP. INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS) 07/09/1999
K854799 J. H. EMERSON CO. EMERSON MODEL 3MV-OAA ALARM MODULE 12/11/1985
K812587 KANTRON CARDIOVASCULAR, INC. MONO 2 OXYGEN MONITOR 10/06/1981
K880378 LIFECARE SERVICES, INC. LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 09/30/1988
K821392 MARATHON MODEL TPC-1 OXYGEN ANALYZER 07/08/1982
K922438 MARTECH MEDICAL PRODUCTS, INC. PRO2 OXYGEN ANALYZER 03/05/1993
K063488 MAXTEC, INC. MAXO2 CU 02/22/2007
K040484 MAXTEC, INC. MAXO2+, MODEL "A" AND "AE" 06/09/2004
K112402 MAXTEC, LLC ULTRAMAXO2 OXYGEN ANALYER 12/14/2011
K983500 MEDICAL TECHNOLOGY SPECIALISTS, INC. PRO2 CHECK OXYGEN INDICATOR 03/17/1999
K863806 MEDICAL, INC. MODEL A-1 OXYGEN ANALYZER 10/15/1986
K872001 MEDICAL, INC. MODEL TPC-1A OXYGEN ANALYZER 06/15/1987
K812040 MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. OXYGEN MONITOR 140/141 09/21/1981
K894918 MENNEN MEDICAL, INC. HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. 10/31/1989
K935364 MINE SAFETY APPLIANCES, CO. MINIOX 1000 OXYGEN CONCENTRATION INDICATOR 06/14/1994
K961644 MINE SAFETY APPLIANCES, CO. MINIOX 3000 OXYGEN MONITOR 07/25/1996
K941793 MOUNTAIN MEDICAL EQUIPMENT, INC. OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) 06/21/1995
K801607 NEOTRONICS, INC. MOM 2 08/07/1980
K942593 NIDEK MEDICAL PRODUCTS, INC. OXYCHEK OXYGEN ANALYZER 05/03/1995
K896359 NIHON KOHDEN AMERICA, INC. AG-820PA FI02 MODULE 03/09/1990
K840392 NOVAMETRIX MEDICAL SYSTEMS, INC. NOVOX OXYGEN ANALYZER 400 02/27/1984
K853082 OHMEDA MEDICAL OHMEDA 5120 OXYGEN MONITOR 07/31/1985
K882743 OHMEDA MEDICAL OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR) 08/24/1988
K792356 OXEQUIP HEALTH IND. OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR 12/04/1979
K833496 OXEQUIP HEALTH IND. OXYGEN MONITOR/CONTROLLER 12/16/1983
K971084 OXIGRAF, INC. MODEL 02 OXYGEN ANALYZER 07/21/1998
K890958 OXITRON MEDICAL PRODUCTS OXITRON OXYGEN ANALYZER 05/22/1989
K890144 OXITRON MEDICAL PRODUCTS OXITRON OXYGEN SENSOR 05/25/1989
K781209 OXYAIR ENGINEERING, INC. MONITOR, OXYGEN, MODEL 3000A 08/14/1978
K951038 OXYCHECK, INC. OXYCHECK OXYGEN MONITOR 01/11/1996
K010318 PENLON LTD. PRIMA OXYGEN MONITOR 07/23/2001
K063096 PRECISION MEDICAL, INC. PRECISION OXYGEN MONITOR 02/27/2007
K891674 PREEMICARE CORP. NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 08/31/1989
K920338 PURITAN BENNETT CORP. COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR 08/27/1992
K791199 RULE MEDICAL INSTRUMENTS, INC. ANESTHESIA OXYGEN ANALYZER MODEL 101 08/03/1979
K873068 SALTER INSTRUMENTATION, INC. OXYGEN ANALYZER MODEL 800 SERIES 10/20/1987
K840361 SALTER LABS OXYGEN ANALYZER 200 02/17/1984
K881663 SALTER LABS OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES 08/19/1988
K881473 SALTER LABS SL01 OXYGEN ANALYZER 06/16/1988
K881472 SALTER LABS SL02 OXYGEN ANALYZER 06/16/1988
K953351 SEATRONICS CO. SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS 10/16/1995
K010382 SENSIDYNE, INC. 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I 03/01/2001
K000700 SENSIDYNE, INC. SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR 08/31/2000
K760338 SHERWOOD MEDICAL INDUSTRIES MONITOR, RESP. OXYGEN (TOP) 08/11/1976
K861625 SIEMENS ELEMA AB SERVO GAS MONITOR 120 05/02/1986
K991884 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS FIO2 SENSOR 11/03/1999
K896427 SPACELABS, INC. SPACELABS' MODEL 90514, MULTIGAS ANALYZER 01/24/1990
K811702 STANLEY AVIATION CORP. MODEL 381 HOME OXYGEN SENTRY 07/16/1981
K780448 TAYLOR INSTRUMENT ANALYTICS CO. TRANSPORTABLE OXYGEN PURITY ANALYZER 04/19/1978
K024155 TELEDYNE ANALYTICAL INSTRUMENTS MX 300 OXYGEN MONITOR 07/17/2003
K001095 TELEDYNE ANALYTICAL INSTRUMENTS OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 06/30/2000
K024228 TELEDYNE ANALYTICAL INSTRUMENTS RX300 OXYGEN ANALYZER 07/17/2003
K963177 TELEDYNE BROWN ENGINEERING TED 191 11/13/1997
K990403 TELEDYNE ELECTRONIC TECHNOLOGIES TED 200T7 OXYGEN MONITOR 02/03/2000
K990457 TELEDYNE ELECTRONIC TECHNOLOGIES TED 60T OXYGEN ANALYZER 11/09/1999
K823449 THORATEC LABORATORIES CORP. RESPIRATORY GAS ANALYZER 01/05/1983
K973545 VACUMED, DIV. OF VACUMETRICS, INC. VACU*MED GOLD EDITION OXYGEN GAS ANALYZER 05/26/1998
K862113 VASCULAR TECHNOLOGY INCORPORATED NO. 100352 GALVANIC OXYGEN SENSOR 06/19/1986
K852275 VASCULAR TECHNOLOGY INCORPORATED VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR 06/20/1985
K890058 VASCULAR TECHNOLOGY INCORPORATED VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM 11/21/1989
K922738 VASCULAR TECHNOLOGY INCORPORATED VTI OXYGEN ANALYZER 01/27/1993
K963415 VENTREX, LLC. VENTREX OXYGEN SENSOR 11/25/1996
K812854 VENTRONICS, DIV OF HUDSON OXYGEN THERAPY SALES CO. VENTRONICS #5590 ECII OXYGEN MONITOR 11/06/1981
K812855 VENTRONICS, DIV OF HUDSON OXYGEN THERAPY SALES CO. VENTRONICS #5595 ECII OXYGEN ANALYZER 11/06/1981
K810571 VICKERS AMERICA MEDICAL CORP. NEOCARE OXYGEN MONITOR 03/11/1981
K854599 VICKERS LTD. VICKERS MEDICAL MODEL 273 OXYGEN MONITOR 11/27/1985
K823231 YELLOW SPRINGS INSTRUMENT CO., INC. YSI #2600 MULTI-CHANNEL DUAL-DISPLAY 12/07/1982
K823232 YELLOW SPRINGS INSTRUMENT CO., INC. YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP 12/07/1982


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