OMV

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Ultrasonic Body Composition Analyzer

Device class

Class II (moderate risk)

Regulation

21 CFR 870.2770

Medical specialty

Cardiovascular

Flags

Third-party review eligible

FDA 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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