FDA 510(k) Application Details - K172482

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K172482
Device Name	Oximeter
Applicant	Covidien 6135 Gunbarrel Avenue Boulder, CO 80301 US Other 510(k) Applications for this Company
Contact	Mia M. Ware 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	08/16/2017
Decision Date	12/15/2017
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