FDA 510(k) Application Details - K192869

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K192869
Device Name	System, Perfusion, Kidney
Applicant	Pragonix Technologies Suite 408, 639 Granite Street Braintree, MA 02184 US Other 510(k) Applications for this Company
Contact	Lisa Anderson Other 510(k) Applications for this Contact
Regulation Number	876.5880   More FDA Info for this Regulation Number
Classification Product Code	KDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2019
Decision Date	01/16/2020
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review