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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 K253767
Device Name UB ERP System
Applicant
Universal Brain
212-214 Homer Ave.
Palo Alto,  CA  94301
Applicant Contact Kazutaka Okuda
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWJ   GWQ  
Date Received11/25/2025
Decision Date 06/30/2026
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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