The following data is part of a premarket notification filed by Intelametrix, Inc with the FDA for Bodymetrix Bx2000.
Device ID | K082147 |
510k Number | K082147 |
Device Name: | BODYMETRIX BX2000 |
Classification | Ultrasonic Body Composition Analyzer |
Applicant | INTELAMETRIX, INC 6246 PRESTON AVENUE Livermore, CA 94551 |
Contact | Heidi Stark |
Correspondent | Heidi Stark INTELAMETRIX, INC 6246 PRESTON AVENUE Livermore, CA 94551 |
Product Code | OMV |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-30 |
Decision Date | 2009-03-20 |
Summary: | summary |