The following data is part of a premarket notification filed by Shenzhen Jumper Medical Equipment Co., Ltd. with the FDA for Electronic Blood Pressure Monitor.
| Device ID | K182495 |
| 510k Number | K182495 |
| Device Name: | Electronic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Jumper Medical Equipment Co., Ltd. D Building, No. 71, Xintian Road, Fuyong Street, Baoan District Shenzhen, CN 518103 |
| Contact | Jinhui Tang |
| Correspondent | Jinhui Tang Shenzhen Jumper Medical Equipment Co., Ltd. D Building, No. 71, Xintian Road, Fuyong Street, Baoan District Shenzhen, CN 518103 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-11 |
| Decision Date | 2019-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810038630028 | K182495 | 000 |
| 10891040000276 | K182495 | 000 |
| 00197644700561 | K182495 | 000 |