Holder, Infant Position

Device Code: 2603

Product Code(s): FRP

Device Classification Information

Device Type ID2603
Device NameHolder, Infant Position
Regulation DescriptionPediatric Position Holder.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(k)
CFR Regulation Number880.5680 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFRP
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID2603
DeviceHolder, Infant Position
Product CodeFRP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPediatric Position Holder.
CFR Regulation Number880.5680 [🔎]
TPLC Last Update: 2019-04-02 20:15:59

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