Calculator, Pulmonary Function Interpretor (diagnostic)

Device Code: 72

Product Code(s): BZM

Device Classification Information

Device Type ID72
Device NameCalculator, Pulmonary Function Interpretor (diagnostic)
Regulation DescriptionDiagnostic Pulmonary-function Interpretation Calculator.
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 Number868.1900 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBZM
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 ID72
DeviceCalculator, Pulmonary Function Interpretor (diagnostic)
Product CodeBZM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionDiagnostic Pulmonary-function Interpretation Calculator.
CFR Regulation Number868.1900 [🔎]
TPLC Last Update: 2019-04-02 19:27:51

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