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Panels › Anesthesiology › Product code CCL · Class 2

Analyzer, Gas, Oxygen, Gaseous-Phase

Regulation 868.1720

1510(k)s in 12 months (122 all time)
0recalls in 12 months (5 all time)
3recalls that name a 510(k)
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Top companies in CCL

Company510(k)sRecalls
Maxtec, Inc.50
Salter Labs50
Catalyst Research Corp.40
Ceramatec, Inc.40
GE Healthcare13
Teledyne Analytical Instruments31
Vascular Technology Incorporated40
Analytical Industries, Inc.30
Hewlett-Packard Co.30
Bio-Med Devices, Inc.20
Decided510(k)Device and applicantCode
Jul 30, 2026K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
Salter Labs
CCL
Aug 11, 2025K251245OxyMinder Pro (10310)
Bio-Med Device, Inc.
CCL
Apr 24, 2025K250002Smart Check O2 (MA0236)
Life Spark Medical, LLC
CCL
Apr 1, 2023K221734Maxtec MaxO2 ME+p
Maxtec, LLC
CCL
Aug 19, 2022K213933Percent Oxygen Sensors
Careox, LLC
CCL
Mar 17, 2022K213948OxyMinder
Bio-Med Devices, Inc.
CCL
May 2, 2018K173807Accu O2 Oxygen Analyzer
Precision Medical, Inc.
CCL
Jun 10, 2016K153659MaxO2ME
Maxtec, LLC
CCL
Feb 28, 2013K123195CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
GE Healthcare Finland Oy, FI
CCL
Jan 23, 2013K122290ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
Envitec-Wismar GmbH
CCL
Dec 14, 2011K112402ULTRAMAXO2 OXYGEN ANALYER
Maxtec, LLC
CCL
Nov 25, 2008K082655ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
Envitec-Wismar GmbH
CCL
Jan 3, 2008K072469DIGIFLO CONCENTRATOR ANALYZER
Digiflo, Inc.
CCL
Feb 27, 2007K063096PRECISION OXYGEN MONITOR
Precision Medical, Inc.
CCL
Feb 22, 2007K063488MAXO2 CU
Maxtec, Inc.
CCL
Apr 5, 2006K053407OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
Analytical Industries, Inc.
CCL
May 25, 2005K051092DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
GE Healthcare
CCL
Jul 15, 2004K041773OXYGEN MEDICELS, CITICELS
City Technology Limited, GB
CCL
Jun 9, 2004K040484MAXO2+, MODEL A AND AE
Maxtec, Inc.
CCL
Jul 17, 2003K024228RX300 OXYGEN ANALYZER
Teledyne Analytical Instruments
CCL
Jul 17, 2003K024155MX 300 OXYGEN MONITOR
Teledyne Analytical Instruments
CCL
Mar 28, 2003K023565OXICHECK
Caradyne, Ltd.
CCL
Jul 23, 2001K010318PRIMA OXYGEN MONITOR
Penlon , Ltd., GB
CCL
Mar 14, 2001K002382'ALL 2000' % OXYGEN ANALYZER
Analytical Industries, Inc.
CCL
Mar 1, 2001K010382100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
Sensidyne, Inc.
CCL
Dec 15, 2000K002384M-XX OXYGEN SENSORS
International Business Strategies
CCL
Aug 31, 2000K000700SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
Sensidyne, Inc.
CCL
Jun 30, 2000K001095OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
Teledyne Analytical Instruments
CCL
Feb 3, 2000K990403TED 200T7 OXYGEN MONITOR
Teledyne Electronic Technologies
CCL
Nov 9, 1999K990457TED 60T OXYGEN ANALYZER
Teledyne Electronic Technologies
CCL
Nov 3, 1999K991884SIEMENS FIO2 SENSOR
Siemens Medical Solutions USA, Inc.
CCL
Jul 9, 1999K984295INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
Invacare Corp.
CCL
Mar 17, 1999K983500PRO2 CHECK OXYGEN INDICATOR
Medical Technology Specialists, Inc.
CCL
Aug 12, 1998K982619HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
Hewlett-Packard Co.
CCL
Jul 21, 1998K971084MODEL 02 OXYGEN ANALYZER
Oxigraf, Inc.
CCL
May 26, 1998K973545VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
Vacumed, Div. of Vacumetrics, Inc.
CCL
Mar 30, 1998K972992CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS
Ceramatec, Inc.
CCL
Mar 4, 1998K973282HANDI OXYGEN ANALYZER
Ceramatec, Inc.
CCL
Nov 13, 1997K963177TED 191
Teledyne Brown Engineering
CCL
Nov 25, 1996K963415VENTREX OXYGEN SENSOR
Ventrex, LLC
CCL
Nov 1, 1996K943824GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
Ametek, Inc.
CCL
Jul 25, 1996K961644MINIOX 3000 OXYGEN MONITOR
Minesafety Appliances Co.
CCL
Jan 11, 1996K951038OXYCHECK OXYGEN MONITOR
Oxycheck, Inc.
CCL
Oct 18, 1995K952736PERCENT OXYGEN SENSOR
Analytical Industries, Inc.
CCL
Oct 16, 1995K953351SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS
Seatronics Co.
CCL
Jun 21, 1995K941793OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)
Mountain Medical Equipment, Inc.
CCL
May 10, 1995K944120FI02 SENSING MODULE
Core-M, L.P.
CCL
May 3, 1995K942593OXYCHEK OXYGEN ANALYZER
Nidek Medical Products, Inc.
CCL
Nov 8, 1994K944654OXYGEN CONCENTRATION INDICATOR
Aequitron Medical, Inc.
CCL
Jun 14, 1994K935364MINIOX 1000 OXYGEN CONCENTRATION INDICATOR
Minesafety Appliances Co.
CCL

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