FDA 510(k) Application Details - K150869

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

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510(K) Number K150869
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant Viatom Technology Co., Ltd.
C607,Languang Park, No. 7 Xinxi Road
Hi-Tech Park( north)
Nanshan, Shenzhen 518057 CN
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Contact Zhou Saixin
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 04/01/2015
Decision Date 12/10/2015
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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