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 | K193348 |
| 510k Number | K193348 |
| Device Name: | Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Viatom Technology Co., Ltd. 4E, Building 3, Tingwei Industrial Park, No.6, Liufang Road Block 67, Xin'an Street, Baoan District Shenzhen, CN 518101 |
| Contact | Zhou Saixin |
| Correspondent | Lucy Yan Shenzhen Viatom Technology Co., Ltd. 4205-4210#, Shenzhen International Chamber Of Commerce Tower 168#, Fuhua 3 Road, Futian District Shenzhen, CN 518048 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-03 |
| Decision Date | 2020-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06934440101017 | K193348 | 000 |
| 06934440100850 | K193348 | 000 |
| 00860011532828 | K193348 | 000 |