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 | K161530 |
| 510k Number | K161530 |
| Device Name: | Bluetooth Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BLDG C, FUHAI INDUSTRIAL ZONE, FUHAI RD, FUYONG TOWN, BAOAN, Shenzhen, CN 518000 |
| Contact | Dacheng Gong |
| Correspondent | Field. Fu SHENZHEN JOYANTECH CONSULTING CO., LTD. 2032#, INTERNATIONAL MAYOR COMMUNICATION CENTER, SHIZHOU SHIZHOU ZHONG ROAD 55#, NA Shenzhen, CN 518100 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2017-03-31 |