FDA 510(k) Application Details - K203331

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K203331
Device Name	Amplifier, Physiological Signal
Applicant	CGX, LLC 8445 Camino Sante Fe, Suite 104 San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Spencer Linton 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	11/12/2020
Decision Date	05/20/2021
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	Y
Expedited Review