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FDA 510(k) Application Details - K213879
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K213879
Device Name
Electrode, Cutaneous
Applicant
Bozhou Rongjian Medical Appliance Co.,Ltd.
Jianghuai Supply Base, Zhongkai Group, Mengcheng County
Bozhou 233500 CN
Other 510(k) Applications for this Company
Contact
Zhifang Wu
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/13/2021
Decision Date
01/05/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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