FDA 510(k) Application Details - K191018

Device Classification Name	Oximeter, Reprocessed   More FDA Info for this Device
510(K) Number	K191018
Device Name	Oximeter, Reprocessed
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	NLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2019
Decision Date	07/03/2019
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