Vaginoscope And Accessories

Device Code: 4020

Product Code(s): MOK

Device Classification Information

Device Type ID4020
Device NameVaginoscope And Accessories
Regulation DescriptionColposcope.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission Type510(k)
CFR Regulation Number884.1630 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMOK
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 ID4020
DeviceVaginoscope And Accessories
Product CodeMOK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionColposcope.
CFR Regulation Number884.1630 [🔎]
TPLC Last Update: 2019-04-02 20:41:46

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