The following data is part of a premarket notification filed by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd with the FDA for Electronic Blood Pressure Monitor.
|Device Name:||Electronic Blood Pressure Monitor|
|Classification||System, Measurement, Blood-pressure, Non-invasive|
|Applicant||Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Yunyang Industrial Park Danyang, CN 212300|
Emergo Global Consulting , LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
|CFR Regulation Number||870.1130 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|