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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 K860051
Device Name MODEL 8604 OXYGEN/PULSE MONITOR
Original Applicant
NONIN MEDICAL, INC.
415 birchwood ave.
white bear lake,  MN  55110
Original Contact neal f nordling
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/06/1986
Decision Date 06/05/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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