K092431 is an FDA 510(k) clearance for the BODY COMPOSITION ANALYZER, MODEL: IOI 353. 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 October 8, 2009, 62 days after receiving the submission on August 7, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K092431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2009 |
| Decision Date | October 08, 2009 |
| Days to Decision | 62 days |
| Submission Type | Special |
| 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 |