The following data is part of a premarket notification filed by Zhongshan Transtek Electronics Co., Ltd. with the FDA for Transtek Wrist Blood Pressure Monitor.
| Device ID | K122482 |
| 510k Number | K122482 |
| Device Name: | TRANSTEK WRIST BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH ZONE Chengdu, CN 610041 |
| Contact | Leo Wang |
| Correspondent | Leo Wang ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH ZONE Chengdu, 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 | 2012-08-14 |
| Decision Date | 2012-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817746020069 | K122482 | 000 |
| 00817746020038 | K122482 | 000 |
| 10875011006078 | K122482 | 000 |
| 10875011006061 | K122482 | 000 |
| 10875011006054 | K122482 | 000 |
| 00850253007192 | K122482 | 000 |