FDA 510(k) Application Details - K211561

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K211561
Device Name	Oximeter, Tissue Saturation
Applicant	Covidien, llc 6135 Gunbarrel Avenue Boulder, CO 80301 US Other 510(k) Applications for this Company
Contact	Megan Elliott 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	05/20/2021
Decision Date	12/05/2021
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