Ep Medsystems, Ep-Workmate

• • Terminated Z-1422-2009 FDA Unclassified (pre-2012) ·initiated 23 Mar 2009 ·on shared 510(k) K994011

  Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line is not fused. The hot line in fused. Clause 57.6 calls for both lines to be fused.

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

510(k) Number

K994011 ↗

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

• ViewMate Ultrasound Imaging System

  Class II

  FDA 510(k) K031066 Active Cleared 17 Oct 2003

• Procath Locking Peel-Away Introducer/Peel-Away Introducer Set

  Class II

  FDA 510(k) K961513 Active Cleared 13 May 1996

See all devices from Ep Medsystems →