Analyzer, Gas, Water Vapor, Gaseous-phase

Device Code: 32

Product Code(s): BXA

Device Classification Information

Device Type ID32
Device NameAnalyzer, Gas, Water Vapor, Gaseous-phase
Regulation DescriptionWater Vapor 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) Exempt
CFR Regulation Number868.1975 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBXA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID32
DeviceAnalyzer, Gas, Water Vapor, Gaseous-phase
Product CodeBXA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionWater Vapor Analyzer.
CFR Regulation Number868.1975 [🔎]
TPLC Last Update: 2019-04-02 19:27:09

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