Ep-4 Clinical Stimulator

• • Terminated Z-1422-2009 FDA Unclassified (pre-2012) ·initiated 23 Mar 2009

  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.

• • 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

K040207 ↗

FDA Product Code

JOQ

Device Class

Class II

Regulation

21 CFR Part 870.1750

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Modification of Procath Electrophysiology Catheter, Ep Medsystems Electrophysiology Catheter

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  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

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