Fresenius Liberty Cycler

• • Terminated Z-0693-2016 FDA Class II ·initiated 15 Dec 2015

  The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).

510(k) Number

K123630 ↗

FDA Product Code

FKX

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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