Pelvimeter, External

Device Code: 3916

Product Code(s): HER

Device Classification Information

Device Type ID3916
Device NamePelvimeter, External
Regulation DescriptionObstetric-gynecologic General Manual Instrument.
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) Exempt
CFR Regulation Number884.4520 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHER
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3916
DevicePelvimeter, External
Product CodeHER
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionObstetric-gynecologic General Manual Instrument.
CFR Regulation Number884.4520 [🔎]
TPLC Last Update: 2019-04-02 20:39:59

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