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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 K102715
Device Name REGIONAL OXIMETER
Original Applicant
NONIN MEDICAL, INC.
13700 1st ave. north
plymouth,  MN  55441 -5443
Original Contact lori m mitchell
Regulation Number870.2700
Classification Product Code
MUD  
Date Received09/20/2010
Decision Date 12/17/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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