Meter, Airway Pressure (inspiratory Force)

Device Code: 42

Product Code(s): BXR

Device Classification Information

Device Type ID42
Device NameMeter, Airway Pressure (inspiratory Force)
Regulation DescriptionInspiratory Airway Pressure Meter.
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)
CFR Regulation Number868.1780 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBXR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID42
DeviceMeter, Airway Pressure (inspiratory Force)
Product CodeBXR
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionInspiratory Airway Pressure Meter.
CFR Regulation Number868.1780 [🔎]
TPLC Last Update: 2019-04-02 19:27:18

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