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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter, tissue saturation
510(k) Number K190560
Device Name SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
Applicant
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth,  MN  55441
Applicant Contact Nancy DeAngelo
Correspondent
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth,  MN  55441
Correspondent Contact Nancy DeAngelo
Regulation Number870.2700
Classification Product Code
MUD  
Date Received03/05/2019
Decision Date 05/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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