Pure Global
FDA product code LHP

System, Telethermographic (Sole Diagnostic Screen)

Obstetrics/Gynecology·Class 3·21 CFR 884.2980
US regulatory classifications
US Product Code (FDA)
LHP
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US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 884.2980
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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 (Sole Diagnostic Screen) 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.