FDA 510(k) Application Details - K181738

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K181738
Device Name	Oximeter
Applicant	Surgical Instrument Service and Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 US Other 510(k) Applications for this Company
Contact	Stephanie Boyle Mays 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	07/02/2018
Decision Date	03/22/2019
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