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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
Applicant
CAS MEDICAL SYSTEMS, INC.
44 east industrial rd.
branford,  CT  06405
Contact ron jeffrey
Regulation Number870.2300
Classification Product Code
MWI  
Date Received10/10/2006
Decision Date 12/11/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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