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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 K141496
Device Name MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
Applicant
REFLECTANCE MEDICAL, INC.
116 FLANDERS ROAD, SUITE 1000
WESTBOROUGH,  MA  01581
Applicant Contact Nandini Murthy
Correspondent
REFLECTANCE MEDICAL, INC.
116 FLANDERS ROAD, SUITE 1000
WESTBOROUGH,  MA  01581
Correspondent Contact Nandini Murthy
Regulation Number870.2700
Classification Product Code
MUD  
Subsequent Product Code
CBZ  
Date Received06/06/2014
Decision Date 08/04/2014
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
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