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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 K102350
Model MODEL 3150
Device Name PULSE 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
DQA  
Date Received08/19/2010
Decision Date 12/22/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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