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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 K052669
Device Name AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100
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 Received09/30/2005
Decision Date 12/23/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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