FDA 510(k) Application Details - K132033

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

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510(K) Number K132033
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant NOBLITT & RUELAND
5405 ALTON PARKWAY
SUITE A530
IRVINE, CA 92604-3718 US
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Contact MARC GOODMAN
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 07/01/2013
Decision Date 12/04/2013
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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