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 | K130325 |
| 510k Number | K130325 |
| Device Name: | ARM AUTOMATIC BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. KEJI NAN NO. 12 ROAD, HI-TECH PARK Shenzhen, Guangdong, CN 518057 |
| Contact | Ivy Chen |
| Correspondent | Ivy Chen SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. KEJI NAN NO. 12 ROAD, HI-TECH PARK 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 | 2013-02-08 |
| Decision Date | 2013-12-24 |
| Summary: | summary |