FDA 510(k) Application Details - DEN200076

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200076
Device Name	ORi
Applicant	Masimo Corporation 52 Discovery Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Linus Park Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2020
Decision Date	10/12/2023
Decision	DENG -
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review