K131394 is an FDA 510(k) clearance for the TRANSTEK GLASS BODY FAT ANALYZER. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Guangdong Transtek Medical Electronics Co., Ltd. (Chengdu, Sichuan, CN). The FDA issued a Cleared decision on September 18, 2013, 126 days after receiving the submission on May 15, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K131394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2013 |
| Decision Date | September 18, 2013 |
| Days to Decision | 126 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 |