FDA 510(k) Application Details - K102854

Device Classification Name Electrocardiograph

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510(K) Number K102854
Device Name Electrocardiograph
Applicant EDAN INSTRUMENTS, INC.
NANHAI ROAD 1019#
NANSHEN
SHENZHEN, GUANGDONG 518067 CN
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Contact YUE QIUHONG (TRACY)
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 09/29/2010
Decision Date 12/03/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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