FDA 510(k) Application Details - K233403

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K233403
Device Name	Electroencephalograph
Applicant	Zeto, Inc. 4917 Waters Edge Dr. Suite #221 Raleigh, NC 27606 US Other 510(k) Applications for this Company
Contact	Aswin Gunasekar Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2023
Decision Date	04/30/2024
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