FDA product code HEI
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Obstetrics/Gynecology·Class 2·21 CFR 884.2660
US regulatory classifications
- US Product Code (FDA)
- HEIView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 884.2660View CFR Regulation →
- Medical specialty
- Obstetrics/Gynecology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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About this record
Monitor, Heart-Valve Movement, Fetal, Ultrasonic is a medical device type in the Obstetrics/Gynecology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.