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FIL — System, Dialysate Delivery, Single Pass Class II

FDA Device Classification

Classification Details

Product Code
FIL
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K011741hemametricsCRIT-LINE MONITOR III TQA (CLM TQA)July 23, 2002
K901038baxter healthcareSPS 550-IPS (INTEGRATED PATIENT STATION)April 19, 1990
K890329fresenius usaFRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEMMay 11, 1989
K790824cyberexREPGREEN ULTRAFILTRATION MONITORJune 27, 1979
K781633extracorporeal medical specialitiesULTRAFILTRATION SCALEDecember 7, 1978
K771875travenol laboratoriesULTRAFILTRATION MONITOR 5M9034November 30, 1977
K771227gambroAK-10August 2, 1977
K770137travenol laboratoriesNEGATIVE PRESSURE ADAPTER 5M1350February 1, 1977