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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 K053130
Device Name ONYX II FINGER PULSE OXIMETER, MODEL 9550
Original Applicant
NONIN MEDICAL, INC.
13700 1st ave. north
plymouth,  MN  55441 -5443
Original Contact lori m roth
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/08/2005
Decision Date 01/11/2006
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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