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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 K192900
Device Name H500 Multi-Sensing Oximetry System
Applicant
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Applicant Contact Kim E Aves
Correspondent
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Correspondent Contact Brent Geiger
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
MUD  
Date Received10/15/2019
Decision Date 06/29/2020
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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