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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 K945290
Device Name 8500A PULSE OXIMETER
Applicant
Nonin Medical, Inc.
2605 Fernbrook Lane, N.
Plymouth,  MN  55447 -4755
Applicant Contact JERRY ZWEIGBAUM
Correspondent
Nonin Medical, Inc.
2605 Fernbrook Lane, N.
Plymouth,  MN  55447 -4755
Correspondent Contact JERRY ZWEIGBAUM
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/31/1994
Decision Date 02/11/1997
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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