Ep-Workmate

• • Terminated Z-1156-2009 FDA Unclassified (pre-2012) ·initiated 13 Feb 2009

  Installation problem: there is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury.

510(k) Number

K070706 ↗

FDA Product Code

DQK

Device Class

Class II

Regulation

21 CFR Part 870.1425

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Procath Electrophysiology Catheter, Ep Medsystems Electrophysiology Catheter

  Class II

  FDA 510(k) K984150 Active Cleared 22 Feb 1999

• Ep-Workmate with Rpm System

  Class II

  FDA 510(k) K032225 Active Cleared 20 Aug 2003

• Ep-Workmate

  Class II

  FDA 510(k) K063113 Active Cleared 27 Oct 2006

• Modification of Procath Electrophysiology Catheter, Ep Medsystems Electrophysiology Catheter

  Class II

  FDA 510(k) K991001 Active Cleared 15 Jul 1999

• Ep Medsystems, Ep-Workmate

  Class II

  FDA 510(k) K994011 Active Cleared 23 Mar 2000

• ViewMate Ultrasound Imaging System

  Class II

  FDA 510(k) K031066 Active Cleared 17 Oct 2003

See all devices from Ep Medsystems →