The following data is part of a premarket notification filed by Shenzhen Pump Medical System Co., Ltd. with the FDA for Arm Automatic Blood Pressure Monitor.
| Device ID | K161712 |
| 510k Number | K161712 |
| Device Name: | Arm Automatic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 2/F WEST, 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 WEST, M-7 SINOSTEEL BUILDING, MAQUELING ESTATE HI-TECH INDUSTRIAL PARK Nanshan District, Shenzhen, CN 518057 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-21 |
| Decision Date | 2017-04-05 |
| Summary: | summary |