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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 K260907
Device Name BIS™ Advance pEEG Module
Applicant
Covidien LP
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact Monica Gupta
Correspondent
Covidien LP
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact Monica Gupta
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received03/19/2026
Decision Date 08/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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