The following data is part of a premarket notification filed by Shenzhen Kingyield Technology Co., Ltd. with the FDA for King`yield Wrist Blood Pressure Monitor, Model Bp201.
| Device ID | K083043 |
| 510k Number | K083043 |
| Device Name: | KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. FUHAI ROAD FUYONG TOWN, BAOAN DISTRICT Shenzhen, Guangdong, CN 518103 |
| Contact | Dacheng Gong |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2008-10-27 |
| Summary: | summary |