FDA 510(k) Application Details - K243199

Device Classification Name	More FDA Info for this Device
510(K) Number	K243199
Device Name	NightWatch+ US
Applicant	LivAssured BV Schipholweg 103 2316 XC Leiden NL Other 510(k) Applications for this Company
Contact	Jolanda Oorthuizen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2024
Decision Date	07/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review