FDA 510(k) Application Details - K203113

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K203113
Device Name	Index-Generating Electroencephalograph Software
Applicant	Masimo Corporation 52 Discovery Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Sindura Penubarthi 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	10/15/2020
Decision Date	02/25/2022
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