FDA 510(k) Application Details - K243746

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K243746
Device Name	Amplifier, Physiological Signal
Applicant	QuantalX Neroscience 1 Hatachana St. Kfar-Saba 4453001 IL Other 510(k) Applications for this Company
Contact	Iftach Dolev Other 510(k) Applications for this Contact
Regulation Number	882.1835   More FDA Info for this Regulation Number
Classification Product Code	GWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2024
Decision Date	03/12/2025
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