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 |