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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K240593
Device Name VEEGix EEG System
Applicant
Neuroservo, Inc.
2065 Parthenais, Suite 416
Montreal,  CA H2K3T1
Applicant Contact Nicolas Tremblay
Correspondent
Neuroservo, Inc.
2065 Parthenais, Suite 416
Montreal,  CA H2K3T1
Correspondent Contact Nicolas Tremblay
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GXY   OMC   ORT  
Date Received03/01/2024
Decision Date 08/23/2024
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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