Monitor, Heart-valve Movement, Fetal, Ultrasonic

Device Code: 3907

Product Code(s): HEI

Device Classification Information

Device Type ID3907
Device NameMonitor, Heart-valve Movement, Fetal, Ultrasonic
Regulation DescriptionFetal Ultrasonic Monitor 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 Number884.2660 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHEI
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 ID3907
DeviceMonitor, Heart-valve Movement, Fetal, Ultrasonic
Product CodeHEI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionFetal Ultrasonic Monitor And Accessories.
CFR Regulation Number884.2660 [🔎]
TPLC Last Update: 2019-04-02 20:39:51

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.