FDA 510(k) Application Details - K082787

Device Classification Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

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510(K) Number K082787
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
#8D,ZHONGXIN ZHONGSHAN MANSION
NO.19,LANE 999,ZHONG SHAN NAN
SHANGHAI, SHANGHAI 20020 CN
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Contact Diana Hong
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 09/23/2008
Decision Date 01/12/2009
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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