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

FDA 510(k) Number Applicant Device Name Decision Date
K943824 AMETEK, INC. GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION 11/01/1996
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
K213948 Bio-Med Devices, Inc. OxyMinder 03/17/2022
K023565 CARADYNE, LTD. OXICHECK 03/28/2003
K213933 CareOx, LLC Percent Oxygen Sensors 08/19/2022
K972992 CERAMATEC, INC. CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS 03/30/1998
K973282 CERAMATEC, INC. HANDI OXYGEN ANALYZER 03/04/1998
K041773 CITY TECHNOLOGY LIMITED OXYGEN MEDICELS, CITICELS 07/15/2004
K072469 DIGIFLO, INC. DIGIFLO CONCENTRATOR ANALYZER 01/03/2008
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
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
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
K063488 MAXTEC, INC. MAXO2 CU 02/22/2007
K040484 MAXTEC, INC. MAXO2+, MODEL A AND AE 06/09/2004
K153659 MAXTEC, LLC MaxO2ME 06/10/2016
K221734 Maxtec, LLC Maxtec MaxO2 ME+p 04/01/2023
K112402 MAXTEC, LLC ULTRAMAXO2 OXYGEN ANALYER 12/14/2011
K983500 MEDICAL TECHNOLOGY SPECIALISTS, INC. PRO2 CHECK OXYGEN INDICATOR 03/17/1999
K961644 MINE SAFETY APPLIANCES, CO. MINIOX 3000 OXYGEN MONITOR 07/25/1996
K971084 OXIGRAF, INC. MODEL 02 OXYGEN ANALYZER 07/21/1998
K951038 OXYCHECK, INC. OXYCHECK OXYGEN MONITOR 01/11/1996
K010318 PENLON LTD. PRIMA OXYGEN MONITOR 07/23/2001
K173807 Precision Medical Inc. Accu O2 Oxygen Analyzer 05/02/2018
K063096 PRECISION MEDICAL, INC. PRECISION OXYGEN MONITOR 02/27/2007
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
K991884 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS FIO2 SENSOR 11/03/1999
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
K973545 VACUMED, DIV. OF VACUMETRICS, INC. VACU*MED GOLD EDITION OXYGEN GAS ANALYZER 05/26/1998
K963415 VENTREX, LLC. VENTREX OXYGEN SENSOR 11/25/1996


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