K130856 is an FDA 510(k) clearance for the BIA / VITALITY ANALYZER, a Analyzer, Body Composition (Class II — Special Controls, product code MNW), submitted by Ipgdx, LLC (Littleton, US). The FDA issued a Cleared decision on November 25, 2013, 242 days after receiving the submission on March 28, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K130856 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 28, 2013 |
| Decision Date | November 25, 2013 |
| Days to Decision | 242 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 |