K062043 is an FDA 510(k) clearance for the BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Omron Healthcare, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on November 7, 2006, 111 days after receiving the submission on July 19, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K062043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2006 |
| Decision Date | November 07, 2006 |
| Days to Decision | 111 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 |