The following data is part of a premarket notification filed by Yibin Junxin Electronics Technology Co., Ltd. with the FDA for Arm Blood Pressure Monitor, Model Ob30, Ob31, Ob32, Ob33.
Device ID | K211532 |
510k Number | K211532 |
Device Name: | Arm Blood Pressure Monitor, Model OB30, OB31, OB32, OB33 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | Yibin Junxin Electronics Technology Co., Ltd. Building B2, No. 136, West Section Of Xinggang Road, Lingang Economic And Technological Devel Yibin, CN 644000 |
Contact | Guan Chaoze |
Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, CN 510700 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-05-18 |
Decision Date | 2022-01-19 |