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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 K893221
Device Name MODEL 8500 HAND HELD PULSE OXIMETER
Applicant
NONIN MEDICAL, INC.
12900 HIGHWAY 55
MINNEAPOLIS,  MN  55441
Applicant Contact NEAL F NORDLING
Correspondent
NONIN MEDICAL, INC.
12900 HIGHWAY 55
MINNEAPOLIS,  MN  55441
Correspondent Contact NEAL F NORDLING
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/27/1989
Decision Date 02/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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