The following data is part of a premarket notification filed by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd with the FDA for Electronic Blood Pressure Monitor.
| Device ID | K200939 |
| 510k Number | K200939 |
| Device Name: | Electronic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Yunyang Industrial Park Danyang, CN 212300 |
| Contact | Rui Li |
| Correspondent | Giselle Zhang Emergo Global Consulting , LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-08 |
| Decision Date | 2020-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06933257914063 | K200939 | 000 |
| 06933257916517 | K200939 | 000 |