FDA 510(k) Application Details - K243324

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K243324
Device Name	Oximeter, Tissue Saturation
Applicant	Masimo Corporation 52 Discovery Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Kertana Shankar 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	10/23/2024
Decision Date	07/17/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review