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Ultrasonic Body Composition Analyzer

FDA product code OMV · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2770
Review panel
GU
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2009-03-20 – 2009-03-20

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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