FDA 510(k) Application Details - K120010

Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)

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510(K) Number K120010
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
INDUSTRIAL HUA WANG
RD DALANG LONGHUA DIST
SHENZHEN, GUANGDONG 518109 CN
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Contact MAOLIN YE
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 01/03/2012
Decision Date 01/19/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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