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, Med-link Disposable Blood Pressure Cuff.
| Device ID | K160530 |
| 510k Number | K160530 |
| Device Name: | Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff |
| Classification | Blood Pressure Cuff |
| Applicant | SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. 4TH FL, BLDG A, YINGTAILONG INDUSTRIAL PRK, DALANG SOUTH ROAD, LONGHUA DISTRICT Shenzhen, CN 518109 |
| Contact | Mina Cheng |
| Correspondent | Mina Cheng SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. 4TH FL, BLDG A, YINGTAILONG INDUSTRIAL PRK, DALANG SOUTH ROAD, LONGHUA DISTRICT 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 | 2016-02-25 |
| Decision Date | 2016-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944414036337 | K160530 | 000 |
| 06944414017497 | K160530 | 000 |
| 06944414017503 | K160530 | 000 |
| 06944414017510 | K160530 | 000 |
| 06944414017527 | K160530 | 000 |
| 06944414021449 | K160530 | 000 |
| 06944414036252 | K160530 | 000 |
| 06944414036276 | K160530 | 000 |
| 06944414036290 | K160530 | 000 |
| 06944414036313 | K160530 | 000 |
| 06944414017480 | K160530 | 000 |