K130777 is an FDA 510(k) clearance for the INBODY, 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 November 25, 2013, 249 days after receiving the submission on March 21, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K130777 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 21, 2013 |
| Decision Date | November 25, 2013 |
| Days to Decision | 249 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 |