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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 K140785
Device Name PULSE OXIMETER
Applicant
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Applicant Contact BRODIE PEDERSEN
Correspondent
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Correspondent Contact BRODIE PEDERSEN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/31/2014
Decision Date 07/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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