The following data is part of a premarket notification filed by Xuzhou Yongkang Electronic Science Technology Co., Ltd with the FDA for Wrist Type Blood Pressure Monitor.
| Device ID | K162616 |
| 510k Number | K162616 |
| Device Name: | Wrist Type Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Xuzhou Yongkang Electronic Science Technology Co., Ltd 4F Building C8,40 Jingshan Road Econonic And Technolgical Development Zone Xuzhou, CN 102628 |
| Contact | Yanli Li |
| Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. Liyuan Town, Tongzhou District, CN 101121 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-20 |
| Decision Date | 2018-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06921745200163 | K162616 | 000 |