The following data is part of a premarket notification filed by Shenzhen Changkun Technology Co., Ltd. with the FDA for Wrist Electronic Sphygmomanometer.
| Device ID | K193386 |
| 510k Number | K193386 |
| Device Name: | Wrist Electronic Sphygmomanometer |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Changkun Technology Co., Ltd. 801, 3 Floor, 4 Floor, 5 Floor, 6 Floor, 7 Floor B Building, NO. 69, Zhenbi Road Shenzhen, CN 518118 |
| Contact | Steve Li |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510000 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-06 |
| Decision Date | 2021-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06951727601879 | K193386 | 000 |