The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Biodynamics Bia 500 Biompedance Body Composition Analyzer.
| Device ID | K051675 |
| 510k Number | K051675 |
| Device Name: | BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER |
| Classification | Analyzer, Body Composition |
| Applicant | BIODYNAMICS CORP. 4554 9TH AVENUE NE, #100 Seattle, WA 98105 |
| Contact | Edward M Rifkin |
| Correspondent | Edward M Rifkin BIODYNAMICS CORP. 4554 9TH AVENUE NE, #100 Seattle, WA 98105 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-23 |
| Decision Date | 2006-03-16 |