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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 K180003
Device Name FORE-SIGHT ELITE Module Tissue Oximeter
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 Received01/02/2018
Decision Date 05/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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