K122388 is an FDA 510(k) clearance for the SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Seca GmbH & Co. KG (Washington, US). The FDA issued a Cleared decision on May 2, 2013, 269 days after receiving the submission on August 6, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K122388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2012 |
| Decision Date | May 02, 2013 |
| Days to Decision | 269 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 |