Transducer, Ultrasonic, Obstetric

Device Code: 3952

Product Code(s): HGL

Device Classification Information

Device Type ID3952
Device NameTransducer, Ultrasonic, Obstetric
Regulation DescriptionObstetric Ultrasonic Transducer And Accessories.
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 Number884.2960 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHGL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID3952
DeviceTransducer, Ultrasonic, Obstetric
Product CodeHGL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionObstetric Ultrasonic Transducer And Accessories.
CFR Regulation Number884.2960 [🔎]
TPLC Last Update: 2019-04-02 20:40:38

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