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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K083892
Device Name FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, 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
DQA  
Date Received12/29/2008
Decision Date 03/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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