FDA 510(k) Application Details - K123556

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

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510(K) Number K123556
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE, WI 53224 US
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Contact AMY YANG
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 11/19/2012
Decision Date 03/22/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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