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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 K910001
Device Name MODEL 8604-FO PULSE OXIMETER
Applicant
Nonin Medical, Inc.
12900 Hwy. 55
Minneapolis,  MN  55441
Applicant Contact NEAL F NORDLING
Correspondent
Nonin Medical, Inc.
12900 Hwy. 55
Minneapolis,  MN  55441
Correspondent Contact NEAL F NORDLING
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/02/1991
Decision Date 07/18/1991
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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