FDA product code HEO
Analyzer, Data, Obstetric
Obstetrics/Gynecology·Class 3·21 CFR 884.2050
US regulatory classifications
- US Product Code (FDA)
- HEOView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 884.2050View CFR Regulation →
- Medical specialty
- Obstetrics/Gynecology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00
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About this record
Analyzer, Data, Obstetric 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.