K072325 is an FDA 510(k) clearance for the BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205. This device is classified as 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 November 30, 2007, 102 days after receiving the submission on August 20, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K072325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2007 |
| Decision Date | November 30, 2007 |
| Days to Decision | 102 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 |