The following data is part of a premarket notification filed by Zhongshan Transtek Electronics Co., Ltd. with the FDA for Transtek Blood Pressure Monitor Model Tmb-986, Tmb-987, Tmb-995.
Device ID | K101681 |
510k Number | K101681 |
Device Name: | TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH DISTRICT Chengdu, Sichuan, CN 610041 |
Contact | Leo Wang |
Correspondent | Leo Wang ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH DISTRICT Chengdu, Sichuan, CN 610041 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-15 |
Decision Date | 2011-05-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817746020007 | K101681 | 000 |
00850253007185 | K101681 | 000 |