Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

Device Code: 111

Product Code(s): CCE

Device Classification Information

Device Type ID111
Device NameAnalyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Regulation DescriptionIndwelling Blood Oxygen Partial Pressure (PO2) Analyzer.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type510(k)
CFR Regulation Number868.1200 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCCE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID111
DeviceAnalyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Product CodeCCE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionIndwelling Blood Oxygen Partial Pressure (PO2) Analyzer.
CFR Regulation Number868.1200 [🔎]
TPLC Last Update: 2019-04-02 19:29:12

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