The following data is part of a premarket notification filed by Visiomed Group Sa with the FDA for Bluetooth Blood Pressure Monitor.
| Device ID | K171668 |
| 510k Number | K171668 |
| Device Name: | Bluetooth Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Visiomed Group SA 112 Av. Kleber Paris, FR |
| Contact | Eric Sebban |
| Correspondent | Dacheng Gong Shenzhen Kingyield Technology Co., Ltd Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan 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 | 2017-06-05 |
| Decision Date | 2018-02-26 |
| Summary: | summary |