FDA 510(k) Application Details - K211370

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K211370
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	Outset Medical, Inc. 3052 Orchard Drive San Jose, CA 95134 US Other 510(k) Applications for this Company
Contact	Saket Bhatt Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	KDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2021
Decision Date	07/29/2022
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