The following data is part of a premarket notification filed by Shenzhen Viatom Technology Co., Ltd. with the FDA for Blood Pressure Monitor.
| Device ID | K190207 |
| 510k Number | K190207 |
| Device Name: | Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Viatom Technology Co., Ltd. Block 67, Xin'an Street, Boan District Shen Zhen, CN 518101 |
| Contact | Zhou Saixin |
| Correspondent | Lucy Yan Shenzhen Joyantech Consulting Co, Ltd. 1122#, International Mayor Communication Center, Baishizhong Nanshan District, Shenzhen, CN 518000 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06934440100720 | K190207 | 000 |