Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)

Device Code: 105

Product Code(s): CBQ

Device Classification Information

Device Type ID105
Device NameAnalyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Regulation DescriptionEnflurane Gas Analyzer.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(k)
CFR Regulation Number868.1500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCBQ
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 ID105
DeviceAnalyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Product CodeCBQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEnflurane Gas Analyzer.
CFR Regulation Number868.1500 [🔎]
TPLC Last Update: 2019-04-02 19:29:08

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