FDA 510(k) Application Details - K131819

Device Classification Name Electrocardiograph

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510(K) Number K131819
Device Name Electrocardiograph
Applicant EDAN INSTRUMENTS, INC.
EQUIPMENTS PARK, NANHAI RD
1019 NO. SHEKOU NANSHAN
SHENZHEN 518067 CN
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Contact QUEENA CHEN
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 06/20/2013
Decision Date 11/22/2013
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 N
Expedited Review



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