FDA 510(k) Application Details - K220631

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K220631
Device Name	Amplifier, Physiological Signal
Applicant	Neurotronics, Inc. 4500 NW 27th Ave STE C2 Gainesville, FL 32606 US Other 510(k) Applications for this Company
Contact	James "Cody" Smith 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	03/04/2022
Decision Date	07/15/2022
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