K051675 is an FDA 510(k) clearance for the BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Biodynamics Corp. (Seattle, US). The FDA issued a Cleared decision on March 16, 2006, 266 days after receiving the submission on June 23, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K051675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2005 |
| Decision Date | March 16, 2006 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MNW — Analyzer, Body Composition |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |