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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Tissue Saturation
510(k) Number K094030
Device Name FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
Applicant
Cas Medical Systems, Inc.
44 E. Industrial Rd.
Branford,  CT  06405
Applicant Contact RON JEFFREY
Correspondent
Cas Medical Systems, Inc.
44 E. Industrial Rd.
Branford,  CT  06405
Correspondent Contact RON JEFFREY
Regulation Number870.2700
Classification Product Code
MUD  
Date Received12/30/2009
Decision Date 12/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00849940
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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