Fresenius 2008T Hemodialysis Machine Model 190573

• • Terminated Z-1693-2013 FDA Class II ·initiated 24 May 2013

  Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)

510(k) Number

K101715 ↗

FDA Product Code

KDI

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

  FDA 510(k) K152953 Active Cleared 5 Nov 2015

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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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