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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Physiological Signal Based Seizure Monitoring System
510(k) Number K251506
Device Name Nelli (Version 7.11)
Applicant
Neuro Event Labs OY
Biokatu 10
Tampere,  FI 33520
Applicant Contact Pierre Pelletier
Correspondent
Neuro Event Labs OY
Biokatu 10
Tampere,  FI 33520
Correspondent Contact Pierre Pelletier
Regulation Number882.1580
Classification Product Code
POS  
Date Received05/16/2025
Decision Date 11/21/2025
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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