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FDA 510(k) Application Details - K171381
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K171381
Device Name
Electrode, Cutaneous
Applicant
ShenZhen Quality Medical Technology Co.,Ltd
5/F, Plant C3, No.1, Nuclear Power Industrial Zone
Guanlan Shijing Community
Shenzhen CN
Other 510(k) Applications for this Company
Contact
Grace Zhao
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
05/11/2017
Decision Date
12/13/2017
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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