The following data is part of a premarket notification filed by Xuzhou Yongkang Electronic Science Technology Co., Ltd with the FDA for Arm Blood Pressure Monitor.
| Device ID | K183491 |
| 510k Number | K183491 |
| Device Name: | Arm Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Xuzhou Yongkang Electronic Science Technology Co., Ltd 4F Building C8, 40 Jingshan Road, Economic And Technological Development Zo Xuzhou, CN 221009 |
| Contact | Kai Li |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-03-24 |