FDA 510(k) Application Details - K033048

Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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510(K) Number K033048
Device Name Monitor, Physiological, Patient(With 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 870.1025

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Classification Product Code MHX
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Date Received 09/29/2003
Decision Date 06/01/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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