FDA 510(k) Application Details - K141076

Device Classification Name Electrode, Cutaneous

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510(K) Number K141076
Device Name Electrode, Cutaneous
Applicant SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
XILIXIAOBAIMANG
SHENZHEN, GUANGDONG 518108 CN
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Contact QILIAN LIU
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 04/25/2014
Decision Date 11/14/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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