The following data is part of a premarket notification filed by Shenzhen Med-link Electronics Tech Co., Ltd with the FDA for Med-link Reusable Blood Pressure Cuff.
| Device ID | K173869 |
| 510k Number | K173869 |
| Device Name: | Med-link Reusable Blood Pressure Cuff |
| Classification | Blood Pressure Cuff |
| Applicant | Shenzhen Med-link Electronics Tech Co., Ltd 4th Floor, Building A, Ying Tailong Ind Park Dalang South Road, Longhua Shenzhen, CN 518109 |
| Contact | Baihan Feng |
| Correspondent | Baihan Feng Shenzhen Med-link Electronics Tech Co., Ltd 4th Floor, Building A, Ying Tailong Ind Park Dalang South Road, Longhua Shenzhen, CN 518109 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-20 |
| Decision Date | 2018-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944414041270 | K173869 | 000 |
| 06944414049245 | K173869 | 000 |
| 06944414049238 | K173869 | 000 |
| 06944414055932 | K173869 | 000 |