FDA 510(k) Application Details - K150352

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

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510(K) Number K150352
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
MINDRAY BUILDING, KEJI 12TH RD
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 02/11/2015
Decision Date 09/02/2015
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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