FDA product code IYM
System, Telethermographic, Infrared
Obstetrics/Gynecology·Class 3·21 CFR 884.2980
US regulatory classifications
- US Product Code (FDA)
- IYMView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 884.2980View CFR Regulation →
- Medical specialty
- Obstetrics/Gynecology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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About this record
System, Telethermographic, Infrared 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.