Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert)

• • Terminated Z-1549-2015 FDA Class II ·initiated 20 Feb 2015 ·on shared 510(k) K121421

  The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

• • Terminated Z-1015-2015 FDA Class II ·initiated 16 Dec 2014 ·on shared 510(k) K121421

  Unqualified power assemblies shipped to customers.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K121421 ↗

FDA Product Code

ONW

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K070177 Active Cleared 29 Mar 2007

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  Class II

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  Unclassified

  FDA 510(k) K050273 Active Cleared 8 Jun 2005

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  Class II

  FDA 510(k) K002892 Active Cleared 5 Apr 2001

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  Class II

  FDA 510(k) K991520 Active Cleared 30 Jul 1999

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