FDA 510(k) Application Details - K132036

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K132036
Device Name System,Network And Communication,Physiological Monitors
Applicant SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
800 MACARTHUR BLVD.
MAHWAH, NJ 07430 US
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Contact RUSSELL OLSEN
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 07/01/2013
Decision Date 07/01/2014
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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