FDA 510(k) Application Details - K182429

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K182429
Device Name	Oximeter, Tissue Saturation
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	870.2700   More FDA Info for this Regulation Number
Classification Product Code	MUD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2018
Decision Date	06/07/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review