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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(k) Number K063087
Device Name MODIFICATION TO MODEL 750 SERIES MONITOR
Original Applicant
CAS MEDICAL SYSTEMS, INC.
44 east industrial rd.
branford,  CT  06405
Original Contact ron jeffrey
Regulation Number870.2300
Classification Product Code
MWI  
Date Received10/10/2006
Decision Date 12/11/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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