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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
Applicant
Nonin Medical, Inc.
415 Birchwood Ave.
White Bear Lake,  MN  55110
Applicant Contact NEAL F NORDLING
Correspondent
Nonin Medical, Inc.
415 Birchwood Ave.
White Bear Lake,  MN  55110
Correspondent Contact NEAL F NORDLING
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/06/1986
Decision Date 06/05/1986
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
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