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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 K001085
Device Name MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
Original Applicant
NONIN MEDICAL, INC.
2605 fernbrook lane, north
minneapolis,  MN  55447 -4755
Original Contact richard p bennett
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/04/2000
Decision Date 05/01/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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