FDA 510(k) Application Details - K223676

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K223676
Device Name	Amplifier, Physiological Signal
Applicant	BrainMatterZ, LLC 19830 FM 1093 Richmond, TX 77407 US Other 510(k) Applications for this Company
Contact	Kevin Wilson 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	12/08/2022
Decision Date	06/01/2023
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