The following data is part of a premarket notification filed by Shenzhen Combei Technology Co., Ltd with the FDA for Digital Blood Pressure Monitor-wrist Style.
| Device ID | K171833 |
| 510k Number | K171833 |
| Device Name: | Digital Blood Pressure Monitor-Wrist Style |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Combei Technology CO., LTD Floor 5, Block B, Building G, Jinxiongda Science Park, Soth Huanguan Road Guanlan, Shenzhen, CN 518110 |
| Contact | Huaguang Meng |
| Correspondent | Migo Yang Shenzhen Joyantech Consulting Co., Ltd. 1122#, INTERNATION MAYOR COMMUNICATION CENTER, BAISHIZHONG RD 55#, Nanshan District, Shenzhen, CN 518000 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-19 |
| Decision Date | 2018-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06948158403936 | K171833 | 000 |
| 06948158403929 | K171833 | 000 |
| 00616784709536 | K171833 | 000 |