K043060 is an FDA 510(k) clearance for the OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400. 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 January 19, 2005, 75 days after receiving the submission on November 5, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K043060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2004 |
| Decision Date | January 19, 2005 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MNW — Analyzer, Body Composition |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |