The following data is part of a premarket notification filed by Shenzhen Coreray Technology Co., Ltd. with the FDA for Reusable Nibp Cuff.
| Device ID | K211747 |
| 510k Number | K211747 |
| Device Name: | Reusable NIBP Cuff |
| Classification | Blood Pressure Cuff |
| Applicant | Shenzhen Coreray Technology Co., Ltd. Floor 5, Building 10, Huangbeiling Jingxuan Industrial Park Yousong Community, Longhua District Shenzhen, CN 518109 |
| Contact | Simon Fan |
| Correspondent | Simon Fan Shenzhen Coreray Technology Co., Ltd. Floor 5, Building 10, Huangbeiling Jingxuan Industrial Park Yousong Community, 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 | 2021-06-07 |
| Decision Date | 2021-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06928737845791 | K211747 | 000 |