K140594 is an FDA 510(k) clearance for the BODY FAT ANALYZER AND SCALE. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Conmo Electronic Company Limited (Echo, US). The FDA issued a Cleared decision on May 30, 2014, 84 days after receiving the submission on March 7, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K140594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2014 |
| Decision Date | May 30, 2014 |
| Days to Decision | 84 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 |