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FDA 510(k) Application Details - K183154
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K183154
Device Name
Electrode, Cutaneous
Applicant
Hong Qiangxing (Shen Zhen) Electronics Limited
4F, Jingcheng Building, Xicheng Industrial Zone
Xixiang Road, Bao'an District
Shenzhen 518126 CN
Other 510(k) Applications for this Company
Contact
Xu Jianhua
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
11/14/2018
Decision Date
03/26/2019
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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