The following data is part of a premarket notification filed by Shenzhen Kingyield Technology Co., Ltd. with the FDA for Kingyield Wrist Blood Pressure Monitor.
| Device ID | K112042 |
| 510k Number | K112042 |
| Device Name: | KINGYIELD WRIST BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. FUHAI RD, RUYONG TOWN BAOAN DIST. Shenzhen, Guangdong, CN 518103 |
| Contact | Dacheng Gong |
| Correspondent | Michael S Ogunleye 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 | 2011-07-18 |
| Decision Date | 2012-02-10 |
| Summary: | summary |