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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 K113656
Model 1100
Device Name CAREGUIDE OXIMETER
Original Applicant
REFLECTANCE MEDICAL INC
116 flaunders road,
suite 1000
westborough,  MA  01581
Original Contact nandini murthy
Regulation Number870.2700
Classification Product Code
MUD  
Date Received12/12/2011
Decision Date 07/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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