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 |