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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 K243199
Device Name NightWatch+ US
Applicant
Livassured BV
Schipholweg 103
Leiden,  NL 2316 XC
Applicant Contact Jolanda Oorthuizen
Correspondent
Livassured BV
Schipholweg 103
Leiden,  NL 2316 XC
Correspondent Contact Jolanda Oorthuizen
Regulation Number882.1580
Classification Product Code
POS  
Date Received10/01/2024
Decision Date 07/12/2025
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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