OMV — Ultrasonic Body Composition Analyzer Class II

FDA Device Classification

Classification Details

Product Code
OMV
Device Class
Class II
Regulation Number
870.2770
Submission Type
Review Panel
GU
Medical Specialty
Cardiovascular
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K082147intelametrixBODYMETRIX BX2000March 20, 2009