Ep-4 Clinical Stimutator

• • Terminated Z-0914-06 FDA Unclassified (pre-2012) ·initiated 4 Apr 2006

  Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation unit-2)-Presence of a DC offset voltage on an output channel-3)-Inability to synchronize with a non-EP MedSystems recording system

510(k) Number

K041442 ↗

FDA Product Code

JOQ

Device Class

Class II

Regulation

21 CFR Part 870.1750

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 →