FDA 510(k) Application Details - K191496

Device Classification Name	Solution-Test Standard-Conductivity, Dialysis   More FDA Info for this Device
510(K) Number	K191496
Device Name	Solution-Test Standard-Conductivity, Dialysis
Applicant	Mesa Laboratories, Inc. 12100 West 6th Avenue Lakewood, CO 80228 US Other 510(k) Applications for this Company
Contact	Jamie Louie Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FKH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2019
Decision Date	08/05/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review