Ultrasonic Body Composition Analyzer
FDA product code OMV · Class II (moderate risk) · 21 CFR 870.2770 · Cardiovascular
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.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K082147 | Bodymetrix BX2000OMV · Traditional | Intelametrix, Inc. | 03/20/2009SE |