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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K221963
Device Name Cumulus Functional Neurophysiology Platform
Applicant
Cumulus Neuroscience Limited
The Innovation Center, Unit 4, Queens Rd.
Belfast,  IE BT3 9DT
Applicant Contact Caroline Kirwan
Correspondent
Qserve Group, Us, Inc.
7949 Beaumont Green E. Dr.
Indianapolis,  IN  46250
Correspondent Contact Patsy J Trisler
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received07/05/2022
Decision Date 04/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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