Crit-Line Blood Chamber with E-Beam

• • Terminated Z-1716-2015 FDA Class II ·initiated 27 Apr 2015

  Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber

510(k) Number

K935958 ↗

FDA Product Code

KOC

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Crit-Line Monitor III (Clm III)

  Class II

  FDA 510(k) K992227 Active Cleared 30 Jul 1999

• Crit-Line Hematocrit Alert

  Class II

  FDA 510(k) K950942 Active Cleared 14 Mar 1995

• Crit-Scan II Monitor

  Class II

  FDA 510(k) K983551 Active Cleared 27 May 1999

• Crit-Line Monitor (Clmiii)

  Class II

  FDA 510(k) K972470 Active Cleared 11 Dec 1997

• Crit-Line Hematocrit Alert (Modification)

  Class II

  FDA 510(k) K953875 Active Cleared 23 Jul 1996

• Modification of Crit-Line Monitor III (Clm III)

  Class II

  FDA 510(k) K982412 Active Cleared 9 Oct 1998

See all devices from In-Line Diagnostics Corp. →