Computer, Oxygen-uptake

Device Code: 71

Product Code(s): BZL

Device Classification Information

Device Type ID71
Device NameComputer, Oxygen-uptake
Regulation DescriptionOxygen Uptake Computer.
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 Number868.1730 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBZL
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 ID71
DeviceComputer, Oxygen-uptake
Product CodeBZL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionOxygen Uptake Computer.
CFR Regulation Number868.1730 [🔎]
TPLC Last Update: 2019-04-02 19:27:50

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