FDA 510(k) Application Details - K150632

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K150632
Device Name System,Network And Communication,Physiological Monitors
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
MINDRAY BUILDING, KENJI 12TH ROAD SOUTH,
HI-TECH INDUSTRIAL PARK, NANSHAN
SHENZHEN 518057 CN
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Contact YANHONG BAI
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 03/11/2015
Decision Date 07/06/2015
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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