The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Blood Pressure Monitor.
| Device ID | K162089 |
| 510k Number | K162089 |
| Device Name: | Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. NO.9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE, SHIJINGSHAN DISTRICT Beijing, CN 100041 |
| Contact | Lei Chen |
| Correspondent | Lei Chen BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. NO.9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE, SHIJINGSHAN DISTRICT Beijing, CN 100041 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-28 |
| Decision Date | 2017-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06942820461880 | K162089 | 000 |