CG-6108 Continuous ECG Monitor and Arrhythmia Detector

• 2 recalls, same reason

  • Terminated Z-0206-2012 FDA Unclassified (pre-2012) ·initiated 26 Sep 2011 ·on shared 510(k) K071995
  • Terminated Z-0208-2012 FDA Unclassified (pre-2012) ·initiated 26 Sep 2011 ·on shared 510(k) K071995

  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

K071995 ↗

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

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  FDA 510(k) K110499 Active Cleared 6 Apr 2011

• Bp Pro Blood Pressure Monitor

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  FDA 510(k) K053395 Active Cleared 23 Dec 2005

• Cg-1000 Personal ECG Transmitter

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  FDA 510(k) K935909 Active Cleared 28 Apr 1995

• Cg-900P Fetal/Maternal Monitor

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  FDA 510(k) K010552 Active Cleared 11 May 2001

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

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  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

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

• What is the CG-6108 Continuous ECG Monitor and Arrhythmia Detector used for?

  The CG-6108 is designed to continuously monitor a one-lead ECG and automatically generate an alarm when its arrhythmia detection algorithm identifies a potential arrhythmia, or to allow the patient to manually trigger an alarm when experiencing transient symptoms that may suggest a cardiac arrhythmia.

• Is the CG-6108 a single-use or reusable device?

  The CG-6108 is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and maintenance, rather than being discarded after a single patient encounter.

• How does the CG-6108 alarm system work?

  The device features two alarm activation methods: automatic triggering by its internal arrhythmia detection algorithm when abnormal heart rhythms are detected, and manual activation by the patient when they feel symptoms, ensuring alerts can be generated both passively and on demand.

• What regulatory pathway was used for the CG-6108?

  The CG-6108 received FDA 510(k) clearance under K071995, demonstrating substantial equivalence to a predicate device, and is classified as a Class II medical device under product code DSI and regulation 870.1025.

• Who manufactures the CG-6108 and where is it authorized for use?

  The CG-6108 is manufactured by Card Guard Scientific Survival, Ltd., located in Rehovot, Israel, and is authorized for marketing in the United States based on its FDA 510(k) clearance.