The following data is part of a premarket notification filed by Shenzhen Kingyield Technology Co., Ltd. with the FDA for Bluetooth Blood Pressure Monitor.
| Device ID | K182018 |
| 510k Number | K182018 |
| Device Name: | Bluetooth Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Kingyield Technology Co., Ltd. Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan District Shenzhen, CN 518000 |
| Contact | Dacheng Gong |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2018-10-06 |
| Summary: | summary |