The following data is part of a premarket notification filed by Xuzhou Maicuff Technology Co.,ltd. with the FDA for Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff.
| Device ID | K151290 |
| 510k Number | K151290 |
| Device Name: | Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff |
| Classification | Blood Pressure Cuff |
| Applicant | XUZHOU MAICUFF TECHNOLOGY CO.,LTD. 8#-2-1106, JINXIUJIAYUAN, JIANGUO WEST ROAD Xuzhou, CN 221006 |
| Contact | Li Zhaoqian |
| Correspondent | Mr. Ray Wang Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, CN 100024 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-15 |
| Decision Date | 2015-06-30 |
| Summary: | summary |