Tube, Thorpe, Uncompensated

Device Code: 55

Product Code(s): BYM

Device Classification Information

Device Type ID55
Device NameTube, Thorpe, Uncompensated
Regulation DescriptionUncompensated Thorpe Tube 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 Number868.2320 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBYM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID55
DeviceTube, Thorpe, Uncompensated
Product CodeBYM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionUncompensated Thorpe Tube Flowmeter.
CFR Regulation Number868.2320 [🔎]
TPLC Last Update: 2019-04-02 19:27:33

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