FDA 510(k) Application Details - K161302

Device Classification Name Electrocardiograph

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510(K) Number K161302
Device Name Electrocardiograph
Applicant EDAN INSTRUMENTS, INC.
3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD 1019#
SHENZHEN 518067 CN
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Contact ERICO LI
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 05/09/2016
Decision Date 07/01/2016
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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