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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 K040589
Device Name MODIFICATION TO AVANT 9600 PULSE OXIMETER
Original Applicant
NONIN MEDICAL, INC.
2605 fernbrook lane, north
minneapolis,  MN  55447 4755
Original Contact john r dalpee
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/09/2004
Decision Date 06/03/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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