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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 K051896
Device Name MODEL 750E 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  
Subsequent Product Codes
BZQ   DRT   FLL  
Date Received07/13/2005
Decision Date 12/16/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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