Transducer, Gas Pressure

Device Code: 39

Product Code(s): BXO

Device Classification Information

Device Type ID39
Device NameTransducer, Gas Pressure
Regulation DescriptionGas Pressure Transducer.
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 Number868.2900 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBXO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID39
DeviceTransducer, Gas Pressure
Product CodeBXO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGas Pressure Transducer.
CFR Regulation Number868.2900 [🔎]
TPLC Last Update: 2019-04-02 19:27:15

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