Sterilizer, Dry Heat

Device Code: 2623

Product Code(s): KMH

Device Classification Information

Device Type ID2623
Device NameSterilizer, Dry Heat
Regulation DescriptionDry-heat Sterilizer.
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)
Infection Control Devices Branch (INCB)
Submission Type510(k)
CFR Regulation Number880.6870 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKMH
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 ID2623
DeviceSterilizer, Dry Heat
Product CodeKMH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionDry-heat Sterilizer.
CFR Regulation Number880.6870 [🔎]
TPLC Last Update: 2019-04-02 20:16:19

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