The following data is part of a premarket notification filed by Shenzhen Pump Medical System Co., Ltd. with the FDA for Blood Pressure Monitor.
| Device ID | K141416 |
| 510k Number | K141416 |
| Device Name: | 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, Guangdong, CN 518057 |
| Contact | Xie Qiongyu |
| Correspondent | Xie Qiongyu SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 2/F WEST, M-7 SINOSTEEL BUILDING, MAQUELING ESTATE HI-TECH INDUSTRIAL PARK Nanshan District, Shenzhen, Guangdong, CN 518057 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-29 |
| Decision Date | 2014-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06947679701279 | K141416 | 000 |