Cart, Emergency, Cardiopulmonary (excluding Equipment)

Device Code: 73

Product Code(s): BZN

Device Classification Information

Device Type ID73
Device NameCart, Emergency, Cardiopulmonary (excluding Equipment)
Regulation DescriptionCardiopulmonary Emergency Cart.
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 Number868.6175 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBZN
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID73
DeviceCart, Emergency, Cardiopulmonary (excluding Equipment)
Product CodeBZN
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionCardiopulmonary Emergency Cart.
CFR Regulation Number868.6175 [🔎]
Device Problems
Break
2
Sparking
2
Device Inoperable
1
Electrical /Electronic Property Problem
1
Connection Problem
1
Insufficient Information
1
Wheel
1
Total Device Problems 9
TPLC Last Update: 2019-04-02 19:27:52

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