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FDA 510(k) Application Details - K051896
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
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510(K) Number
K051896
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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More FDA Info for this Product Code
Date Received
07/13/2005
Decision Date
12/16/2005
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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