Cg-5108 Act-3l Continuous ECG Monitor and Arrhythmia Detector

• 2 recalls, same reason

  • Terminated Z-0207-2012 FDA Unclassified (pre-2012) ·initiated 26 Sep 2011 ·on shared 510(k) K110499
  • Terminated Z-0208-2012 FDA Unclassified (pre-2012) ·initiated 26 Sep 2011 ·on shared 510(k) K110499

  LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.

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

510(k) Number

K110499 ↗

FDA Product Code

DSI

FDA applicant

Card Guard Scientific Survival , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bp Pro Blood Pressure Monitor

  Class II

  FDA 510(k) K053395 Active Cleared 23 Dec 2005

• Cg-1000 Personal ECG Transmitter

  Class II

  FDA 510(k) K935909 Active Cleared 28 Apr 1995

• Cg-900P Fetal/Maternal Monitor

  Class II

  FDA 510(k) K010552 Active Cleared 11 May 2001

• Card Guard Personal Electrocardiogram Transmitter, Model Cg-6206/6306

  Class II

  FDA 510(k) K000225 Active Cleared 11 Feb 2000

• Cg-6108 Act-Il Continuous ECG Monitor and Arrythmia Detector

  Class II

  FDA 510(k) K101639 Active Cleared 25 Jun 2010

• Card Guard Model Cg-6500

  Class II

  FDA 510(k) K954350 Active Cleared 10 Sep 1996

See all devices from Card Guard Scientific Survival, Ltd. →