FDA 510(k) Application Details - K230693

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K230693
Device Name	Index-Generating Electroencephalograph Software
Applicant	Covidien LLC 6135 Gunbarrel Ave Boulder, CO 80301 US Other 510(k) Applications for this Company
Contact	Moshe J Cohen Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2023
Decision Date	02/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review