510(k) K082147

BODYMETRIX BX2000 by Intelametrix, Inc. — Product Code OMV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 20, 2009
Date Received: July 30, 2008
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Ultrasonic Body Composition Analyzer
Device Class: Class II
Regulation Number: 870.2770
Review Panel: GU
Submission Type

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.