FDA product code OMV

Ultrasonic Body Composition Analyzer

Cardiovascular·Class 2·21 CFR 870.2770
US regulatory classifications
US Product Code (FDA)
OMV
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.2770
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

Intended to measure thickness of a distinctive tissue layer. Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively.

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About this record

Ultrasonic Body Composition Analyzer is a medical device type in the Cardiovascular 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.