510(k) K141145

LIBERTY PDX CYCLER by Fresenius Medical Care Renal Therapies Group, LLC — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2014
Date Received
May 2, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type