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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 K230693
Device Name BIS™ Advance Monitoring System
Applicant
Covidien LLC
6135 Gunbarrel Ave
Boulder,  CO  80301
Applicant Contact Moshe J Cohen
Correspondent
Covidien LLC
6135 Gunbarrel Ave
Boulder,  CO  80301
Correspondent Contact Moshe J Cohen
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received03/13/2023
Decision Date 02/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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