FDA 510(k) Application Details - K171901

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

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510(K) Number K171901
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Mindray Building, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen 518057 CN
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Contact Yanhong Bai
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 06/26/2017
Decision Date 11/15/2017
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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