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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 K112843
Model 9590
Device Name PULSE OXIMETER
Original Applicant
NONIN MEDICAL, INC.
13700 1st ave. north
plymouth,  MN  55441 5443
Original Contact brodie pederson
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/29/2011
Decision Date 04/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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