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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 K254213
Device Name Pascall Sensor Unit (PSU1)
Applicant
Pascall Systems, Inc.
625 Massachusetts Ave.
Cambridge,  MA  02139
Applicant Contact Tuan Le Mau
Correspondent
Steurer Consulting Group
800 Blue Quail Rd.
Keller,  TX  76248
Correspondent Contact Robert Steurer
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GXY   OMC   ORT  
Date Received12/29/2025
Decision Date 08/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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