FDA 510(k) Application Details - K212555

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K212555
Device Name	Oximeter
Applicant	Covidien llc 6135 Gunbarrel Avenue Boulder, CO 80301 US Other 510(k) Applications for this Company
Contact	Anushka Jayaraman Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2021
Decision Date	05/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review