The following data is part of a premarket notification filed by Guangdong Transtek Medical Electronics Co., Ltd with the FDA for Transtek Glass Body Fat Analyzer.
| Device ID | K131394 |
| 510k Number | K131394 |
| Device Name: | TRANSTEK GLASS BODY FAT ANALYZER |
| Classification | Analyzer, Body Composition |
| Applicant | GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD NO.1 FANGHUA STREET, HI-TECH DISTRICT Chengdu, Sichuan, CN 610041 |
| Contact | Leo Wang |
| Correspondent | Leo Wang GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD NO.1 FANGHUA STREET, HI-TECH DISTRICT Chengdu, Sichuan, CN 610041 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2013-09-18 |
| Summary: | summary |