FDA 510(k) Application Details - K234021

Device Classification Name	More FDA Info for this Device
510(K) Number	K234021
Device Name	Masimo Stork
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	More FDA Info for this Regulation Number
Classification Product Code	QYU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2023
Decision Date	05/03/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review