Bodymetrix BX2000
FDA 510(k) K082147 · Intelametrix, Inc.
510(k) numberK082147
Submission
- Device name
- Bodymetrix BX2000
- Applicant
- Intelametrix, Inc.
Livermore, CA, US - Received
- July 30, 2008
- Decision date
- March 20, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMV – Ultrasonic Body Composition Analyzer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- 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.
Questions and answers
When was Bodymetrix BX2000 cleared by the FDA?
Bodymetrix BX2000 (K082147) received a 510(k) decision of Substantially Equivalent on March 20, 2009, 233 days after the submission was received.
What is the product code of K082147?
The FDA product code is OMV – Ultrasonic Body Composition Analyzer, a Class II (moderate risk) device regulated under 21 CFR 870.2770.