K963575 is an FDA 510(k) clearance for the HBF-1000 OMRON BODY COMPOSITION ANALYZER. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Omron Healthcare, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on June 13, 1997, 280 days after receiving the submission on September 6, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K963575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1996 |
| Decision Date | June 13, 1997 |
| Days to Decision | 280 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 |