The following data is part of a premarket notification filed by Zhongshan Transtek Electronics Co., Ltd. with the FDA for Transtek Blood Pressure Monitor.
| Device ID | K123780 |
| 510k Number | K123780 |
| Device Name: | TRANSTEK BLOOD PRESSURE MONITOR |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869876000039 | K123780 | 000 |
| 00869876000053 | K123780 | 000 |
| 10860005787200 | K123780 | 000 |