Purifier, Water, Ultraviolet, Medical

Device Code: 2622

Product Code(s): KMG

Device Classification Information

Device Type ID2622
Device NamePurifier, Water, Ultraviolet, Medical
Regulation DescriptionMedical Ultraviolet Water Purifier.
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 Number880.6710 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKMG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID2622
DevicePurifier, Water, Ultraviolet, Medical
Product CodeKMG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMedical Ultraviolet Water Purifier.
CFR Regulation Number880.6710 [🔎]
TPLC Last Update: 2019-04-02 20:16:18

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