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FDA 510(k) Application Details - K241512
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K241512
Device Name
Electrode, Cutaneous
Applicant
ShenZhen Deliduo Medical Technology Co.,Ltd
4th Floor, Building 11, Phase II, Meilonghu Intelligent Manu
facturing Industry New City, Xinwei Town, Huiyang District,
Huizhou CN
Other 510(k) Applications for this Company
Contact
Andy Liu
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
05/29/2024
Decision Date
01/15/2025
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
FDA Source Information for K241512
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