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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 K191403
Device Name Pulse Oximeter
Applicant
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth,  MN  55441
Applicant Contact Walter Holbein
Correspondent
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth,  MN  55441
Correspondent Contact Walter Holbein
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/24/2019
Decision Date 12/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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