Calibrator, Pressure, Gas

Device Code: 44

Product Code(s): BXX

Device Classification Information

Device Type ID44
Device NameCalibrator, Pressure, Gas
Regulation DescriptionGas Pressure Calibrator.
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 Number868.2620 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBXX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID44
DeviceCalibrator, Pressure, Gas
Product CodeBXX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGas Pressure Calibrator.
CFR Regulation Number868.2620 [🔎]
TPLC Last Update: 2019-04-02 19:27:20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.