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FDA 510(k)

KING OF HEARTS EXPRESS + AF MONITOR

K-Number: K020825 · 2002-04-05

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date2002-04-05
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KING OF HEARTS EXPRESS + AF MONITOR 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 2002-04-05 under 510(k) number K020825. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KING OF HEARTS EXPRESS + AF MONITOR?

KING OF HEARTS EXPRESS + AF MONITOR is a medical device that received FDA 510(k) clearance on 2002-04-05. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K020825.

When did KING OF HEARTS EXPRESS + AF MONITOR receive FDA 510(k) clearance?

KING OF HEARTS EXPRESS + AF MONITOR received FDA 510(k) clearance on 2002-04-05, under 510(k) number K020825.

Who is the listed applicant for KING OF HEARTS EXPRESS + AF MONITOR?

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 KING OF HEARTS EXPRESS + AF MONITOR?

The FDA product code for KING OF HEARTS EXPRESS + AF MONITOR is DSH.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K111745KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDERK110499CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORK101703MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084K101639CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTORK083174HEALTHEPODK082521EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM

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Related Devices (Code: DSH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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.

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