FDA 510(k) Application Details - K130411

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

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510(K) Number K130411
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant CAS MEDICAL SYSTEMS, INC.
44 EAST INDUSTRIAL RD.
BRANFORD, CT 06405 US
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Contact RON JEFFREY
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 02/19/2013
Decision Date 05/29/2013
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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