CCL — Analyzer, Gas, Oxygen, Gaseous-Phase Class II

FDA Device Classification

Classification Details

Product Code
CCL
Device Class
Class II
Regulation Number
868.1720
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251245bio-med deviceOxyMinder Pro (10310)August 11, 2025
K250002life spark medicalSmart Check O2 (MA0236)April 24, 2025
K221734maxtecMaxtec MaxO2 ME+pApril 1, 2023
K213933careoxPercent Oxygen SensorsAugust 19, 2022
K213948bio-med devicesOxyMinderMarch 17, 2022
K173807precision medicalAccu O2 Oxygen AnalyzerMay 2, 2018
K153659maxtecMaxO2MEJune 10, 2016
K123195ge healthcare finlandCARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIESFebruary 28, 2013
K122290envitec-wismarENVITEC MYSIGN O OXYGEN MEASURING DEVICEJanuary 23, 2013
K112402maxtecULTRAMAXO2 OXYGEN ANALYERDecember 14, 2011
K082655envitec-wismarENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOMNovember 25, 2008
K072469digifloDIGIFLO CONCENTRATOR ANALYZERJanuary 3, 2008
K063096precision medicalPRECISION OXYGEN MONITORFebruary 27, 2007
K063488maxtecMAXO2 CUFebruary 22, 2007
K053407analytical industriesOXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000MApril 5, 2006
K051092ge healthcareDATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOVMay 25, 2005
K041773city technology limitedOXYGEN MEDICELS, CITICELSJuly 15, 2004
K040484maxtecMAXO2+, MODEL A AND AEJune 9, 2004
K024155teledyne analytical instrumentsMX 300 OXYGEN MONITORJuly 17, 2003
K024228teledyne analytical instrumentsRX300 OXYGEN ANALYZERJuly 17, 2003