Bed, Rocking, Breathing Assist

Device Code: 118

Product Code(s): CCO

Device Classification Information

Device Type ID118
Device NameBed, Rocking, Breathing Assist
Regulation DescriptionRocking Bed.
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 Number868.5180 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCCO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID118
DeviceBed, Rocking, Breathing Assist
Product CodeCCO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRocking Bed.
CFR Regulation Number868.5180 [🔎]
TPLC Last Update: 2019-04-02 19:29:18

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