FDA 510(k) Application Details - K130234

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

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510(K) Number K130234
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant NUVON, INC.
555 THIRTEENTH STREET NW
WASHINGTON, DC 20004 US
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Contact JONATHAN S KAHAN
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 01/30/2013
Decision Date 03/13/2013
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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