FDA 510(k) Application Details - K241512

Device Classification Name Electrode, Cutaneous

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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
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Contact Andy Liu
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Regulation Number 882.1320

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Classification Product Code GXY
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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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