Crit-Line Clip (Clic)

• • Terminated Z-2044-2016 FDA Class II ·initiated 24 May 2016

  Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.

510(k) Number

K121599 ↗

FDA Product Code

KOC

FDA applicant

Fresenius Medical Care-North America

Device Class

Class II

Regulation

21 CFR Part 876.5820

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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• Fresenius on Line Clearance Monitor with the Addition of Access Flow Determination

  Class II

  FDA 510(k) K991520 Active Cleared 30 Jul 1999

See all devices from Fresenius Medical Care North America →