FDA 510(k) Application Details - K113623

Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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510(K) Number K113623
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant EDAN INSTRUMENTS, INC.
EQUIPMENTS PARK, NANHAI RD
1019 NO.
SHENZHEN 518067 CN
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Contact RANDY JIANG
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 12/05/2011
Decision Date 02/01/2012
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 N
Expedited Review



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