Chair, Posture, For Cardiac And Pulmonary Treatment

Device Code: 56

Product Code(s): BYN

Device Classification Information

Device Type ID56
Device NameChair, Posture, For Cardiac And Pulmonary Treatment
Regulation DescriptionPosture Chair For Cardiac Or Pulmonary Treatment.
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 Number868.5365 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBYN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID56
DeviceChair, Posture, For Cardiac And Pulmonary Treatment
Product CodeBYN
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPosture Chair For Cardiac Or Pulmonary Treatment.
CFR Regulation Number868.5365 [🔎]
Device Problems
Protective Measures Problem
1
Device Operates Differently Than Expected
1
Fail-Safe Problem
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 19:27:34

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