K140045 is an FDA 510(k) clearance for the BODY COMPOSITION ANALYZER, a Analyzer, Body Composition (Class II — Special Controls, product code MNW), submitted by Jawon Medical Co., Ltd. (Kyungsan-City, Kyungsan-Bukdo, KR). The FDA issued a Cleared decision on February 18, 2015, 406 days after receiving the submission on January 8, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K140045 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 08, 2014 |
| Decision Date | February 18, 2015 |
| Days to Decision | 406 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 |