The following data is part of a premarket notification filed by Shenzhen Med-link Electronics Tech Co, Ltd. with the FDA for Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor.
| Device ID | K181154 |
| 510k Number | K181154 |
| Device Name: | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Med-link Electronics Tech Co, Ltd. 4th Fl, Bldg A, Yingtailong Industrial Prk, Dalang South Road, Longhua District Shenzhen, CN 518109 |
| Contact | Baihan Feng |
| Correspondent | Baihan Feng Shenzhen Med-link Electronics Tech Co, Ltd. 4th Fl, Bldg A, Yingtailong Industrial Prk, Dalang South Road, Longhua District Shenzhen, CN 518109 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2019-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944414031950 | K181154 | 000 |
| 06944414031301 | K181154 | 000 |