DeviceClearance

Product code OMV— Cardiovascular

BODYMETRIX BX2000

Classification name
Ultrasonic Body Composition Analyzer
Device class
Class 2
Regulation
21 CFR 870.2770
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OMV under 21 CFR 870.2770, via openFDA

Market context for product code OMV

FDA has cleared 1 device under product code OMV, all in 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OMV

Recent clearances under product code OMV

Data sourced from openFDA. This site is unofficial and independent of the FDA.