Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling

Device Code: 110

Product Code(s): CCC

Device Classification Information

Device Type ID110
Device NameAnalyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Regulation DescriptionIndwelling Blood Carbon Dioxide Partial Pressure (PCO2) 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 Number868.1150 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCCC
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 ID110
DeviceAnalyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Product CodeCCC
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionIndwelling Blood Carbon Dioxide Partial Pressure (PCO2) Analyzer.
CFR Regulation Number868.1150 [🔎]
TPLC Last Update: 2019-04-02 19:29:11

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