The following data is part of a premarket notification filed by Suzhou Minhua Medical Apparatus Supplies Co., Ltd with the FDA for Reusable Blood Pressure Cuff.
| Device ID | K171889 |
| 510k Number | K171889 |
| Device Name: | Reusable Blood Pressure Cuff |
| Classification | Blood Pressure Cuff |
| Applicant | Suzhou Minhua Medical Apparatus Supplies Co., LTD You Yi Industrial Park, Songlin Town, Wujiang Suzhou, CN 215222 |
| Contact | Yang Qidong |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-26 |
| Decision Date | 2017-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858293006448 | K171889 | 000 |
| 20858293006438 | K171889 | 000 |
| 20858293006421 | K171889 | 000 |
| 20858293006414 | K171889 | 000 |