Gauge, Gas Pressure, Cylinder/pipeline

Device Code: 33

Product Code(s): BXH

Device Classification Information

Device Type ID33
Device NameGauge, Gas Pressure, Cylinder/pipeline
Regulation DescriptionGas Pressure Gauge.
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 Number868.2610 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBXH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID33
DeviceGauge, Gas Pressure, Cylinder/pipeline
Product CodeBXH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGas Pressure Gauge.
CFR Regulation Number868.2610 [🔎]
TPLC Last Update: 2019-04-02 19:27:10

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