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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