The following data is part of a premarket notification filed by Bozhou Rongjian Medical Appliance Co.,ltd. with the FDA for Self-adhesive Electrode.
|Device Name:||Self-adhesive Electrode|
|Applicant||Bozhou Rongjian Medical Appliance Co.,Ltd. Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou, CN 233500|
Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, CN 201613
|CFR Regulation Number||882.1320 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|