FDA 510(k)

MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084

K-Number: K101703 · 2010-07-13

ApplicantCard Guard Scientific Survival , Ltd.

Decision Date2010-07-13

Product CodeDSI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 is the device name listed in this FDA 510(k) record. The listed applicant is Card Guard Scientific Survival , Ltd.. It received FDA 510(k) clearance on 2010-07-13 under 510(k) number K101703. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084?

MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 is a medical device that received FDA 510(k) clearance on 2010-07-13. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K101703.

When did MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 receive FDA 510(k) clearance?

MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 received FDA 510(k) clearance on 2010-07-13, under 510(k) number K101703.

Who is the listed applicant for MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084?

The FDA 510(k) record lists Card Guard Scientific Survival , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084?

The FDA product code for MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 is DSI.

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Other records listing Card Guard Scientific Survival , Ltd. as applicant

K111745KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER K110499CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR K101639CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR K083174HEALTHEPOD K082521EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM K081257CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR

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Related Devices (Code: DSI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.