The following data is part of a premarket notification filed by Zhongshan Transtek Electronics Co., Ltd. with the FDA for Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body Analyzer;transtek Glass Body Analyzer.
| Device ID | K102191 |
| 510k Number | K102191 |
| Device Name: | TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER |
| Classification | Analyzer, Body Composition |
| Applicant | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH DISTRICT Chengdu, CN 610041 |
| Contact | Leo Wang |
| Correspondent | Leo Wang ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH DISTRICT Chengdu, CN 610041 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-03 |
| Decision Date | 2011-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817746020304 | K102191 | 000 |