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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Index-Generating Electroencephalograph Software
510(k) Number K172890
Device Name SedLine Sedation Monitor
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Matthew Tiacharoen
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Matthew Tiacharoen
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
GXY   OLT   OMC   ORT  
Date Received09/22/2017
Decision Date 01/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02043938
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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