FDA 510(k) Application Details - K230148

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K230148
Device Name	Amplifier, Physiological Signal
Applicant	DormoTech Medical Ltd. Yitzhak Rabin 21 Afula 33704 IL Other 510(k) Applications for this Company
Contact	Abed Nassir 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	01/19/2023
Decision Date	10/11/2023
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