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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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