Stethoscope, Fetal

Device Code: 3954

Product Code(s): HGN

Device Classification Information

Device Type ID3954
Device NameStethoscope, Fetal
Regulation DescriptionFetal Stethoscope.
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 Number884.2900 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHGN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3954
DeviceStethoscope, Fetal
Product CodeHGN
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionFetal Stethoscope.
CFR Regulation Number884.2900 [🔎]
TPLC Last Update: 2019-04-02 20:40:40

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