FDA 510(k) Application Details - K132026

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

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510(K) Number K132026
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant MINDRAY DS USA, INC.
800 MACARTHUR BLVD
MAHWAH, NJ 07430 US
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Contact RUSSELL OLSEN
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 07/01/2013
Decision Date 12/20/2013
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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