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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 K113215
Model 8004CB, 8004CB-NA 7600, 7600PA
Device Name MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
Original Applicant
NONIN MEDICAL, INC.
13700 1st ave, north
plymouth,  MN  55441
Original Contact brodie pederson
Regulation Number870.2700
Classification Product Code
MUD  
Date Received11/01/2011
Decision Date 05/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Clinical Trials NCT00939224
Reviewed by Third Party No
Expedited Review No
Combination Product No
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