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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 K001930
Device Name MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
Applicant
NONIN MEDICAL, INC.
2605 FERNBROOK LANE, NORTH
MINNEAPOLIS,  MN  55447 -4755
Applicant Contact RICHARD P BENNETT
Correspondent
NONIN MEDICAL, INC.
2605 FERNBROOK LANE, NORTH
MINNEAPOLIS,  MN  55447 -4755
Correspondent Contact RICHARD P BENNETT
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/26/2000
Decision Date 07/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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