Micrometers, Microscope

Device Code: 4997

Product Code(s): KEH

Device Classification Information

Device Type ID4997
Device NameMicrometers, Microscope
Regulation DescriptionMicroscopes And Accessories.
Regulation Medical SpecialtyPathology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.3600 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKEH
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4997
DeviceMicrometers, Microscope
Product CodeKEH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMicroscopes And Accessories.
CFR Regulation Number864.3600 [🔎]
TPLC Last Update: 2019-04-02 20:58:37

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