FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM— 510(k) K921456

Clearance details

Applicant

Fresenius USA, Inc.

Product code

Code FKP

Device class

Class 2

Regulation

21 CFR 876.5820

Advisory panel

Gastroenterology, Urology

Date received

1992-03-27

Decision date

1994-04-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walnut Creek, CA, US

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• Z-0629-2014 — Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K~home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.Class II·Terminated·Fresenius Medical Care Holdings, Inc.·20131112

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K921456.