Flowmeter, Calibration, Gas

Device Code: 45

Product Code(s): BXY

Device Classification Information

Device Type ID45
Device NameFlowmeter, Calibration, Gas
Regulation DescriptionGas Calibration Flowmeter.
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) Exempt
CFR Regulation Number868.2350 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBXY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID45
DeviceFlowmeter, Calibration, Gas
Product CodeBXY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGas Calibration Flowmeter.
CFR Regulation Number868.2350 [🔎]
TPLC Last Update: 2019-04-02 19:27:21

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