The following data is part of a premarket notification filed by Shenzhen Pump Medical System Co., Ltd. with the FDA for Bpump Blood Pressure Cuff.
| Device ID | K151810 |
| 510k Number | K151810 |
| Device Name: | Bpump Blood Pressure Cuff |
| Classification | Blood Pressure Cuff |
| Applicant | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 2/F, M-7 SINOSTEEL BUILDING, MAQUELING ESTATE HI-TECH INDUSTRIAL PARK Nanshan District, Shenzhen, CN 518057 |
| Contact | Xie Qiongyu |
| Correspondent | Migo Yang SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 2/F, M-7 SINOSTEEL BUILDING, MAQUELING ESTATE HI-TECH INDUSTRIAL PARK Nanshan District, Shenzhen, CN 518057 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-02 |
| Decision Date | 2015-12-17 |
| Summary: | summary |