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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 K093306
Model 6500SA, 6500MA
Device Name SINGLE-PATIENT USE DISPOSABLE SENSOR
Original Applicant
NONIN MEDICAL, INC.
13700 1st ave. north
plymouth,  MN  55441 5443
Original Contact lori roth
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/22/2009
Decision Date 03/04/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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