K092786 is an FDA 510(k) clearance for the INBODY, MODELS: 270, R20, R20B, a Analyzer, Body Composition (Class II — Special Controls, product code MNW), submitted by Biospace Corporation Limited (Naples, US). The FDA issued a Cleared decision on March 10, 2010, 181 days after receiving the submission on September 10, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K092786 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 10, 2009 |
| Decision Date | March 10, 2010 |
| Days to Decision | 181 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 |