Mattress, Water, Temperature Regulated

Device Code: 2574

Product Code(s): FOH

Device Classification Information

Device Type ID2574
Device NameMattress, Water, Temperature Regulated
Regulation DescriptionTemperature Regulated Water Mattress.
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) Exempt
CFR Regulation Number880.5560 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFOH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2574
DeviceMattress, Water, Temperature Regulated
Product CodeFOH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTemperature Regulated Water Mattress.
CFR Regulation Number880.5560 [🔎]
TPLC Last Update: 2019-04-02 20:14:59

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