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510(k) Data Aggregation

    K Number
    K131045
    Device Name
    ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
    Manufacturer
    CARDIAC DESIGNS, LLC
    Date Cleared
    2013-05-29

    (44 days)

    Product Code
    DQK, DOK, DPS
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIAC DESIGNS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Enterprise ECG Analysis / Interpretation Software" is a tool used by qualified medical professionals to assist with the assessment of arrhythmias using ambulatory EGG data. The software supports downloading and analyzing data recorded in compatible formats from devices used for arrhythmia diagnostics such as Holter, Event Monitor, ambulatory or resting EGG devices, or other similar devices when assessment of the rhythm is necessary. The software can be electronically interfaced, and perform analysis with data transferred from other computer based EGG systems, such as an EGG management system. The software provides EGG signal processing and analysis on a beat by beat basis. ORS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for the captured data. The software is not for use in life supporting or life sustaining systems or EGG Alarm devices. The software can be integrated into computerized EGG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device. Analysis metrics are provided in a report which is available for clinician review and printing. The reported ECG metrics include beat by beat heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the care provider to render a diagnosis based on clinical judgment and experience.
    Device Description
    Not Found
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    K Number
    K122184
    Device Name
    ECG CHECK
    Manufacturer
    CARDIAC DESIGNS, LLC
    Date Cleared
    2013-02-14

    (206 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIAC DESIGNS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server. Specifically, the ECG Check is indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms: Skipped Beats, Pounding Heart (Palpitations), Heart Racing or Irregular Pulse, Lightheadedness or Faintness, History of Arrhythmias.
    Device Description
    The ECG Check model ECG01-4S is a personal 1 lead ECG Event Monitor specifically designed to operate with an iPhone 4S handset and allows transmissions to the ECG Check web center. Future iterations will be designed for other handsets, but will not change the fundamental features and capabilities described herein. It will record a preselected amount of user ECG activity, as directed by the user. Typical configuration is to record 30 seconds of ECG per event. The ECG Check, when used in conjunction with the ECG Check web center, uses standard analysis of ECG by the web-based engine for objective assessment of the user in terms similar to a stoplight (Green, Yellow, Red). With a physician prescription, the user will be provided access to be able to trend their results and generate reports to provide to their physician or other caregivers. While performing the recording, the results are continuously sent to the iPhone by secure Bluetooth connection technology and, with a physician prescription, displayed for quality and observation purposes on the iPhone ECG Check application. Users without a physician prescription will not be able to view the waveform. The data can then be stored locally and/or transmitted to the ECG Check web center for analysis and assessment by qualified professionals. The ECG Check web center provides privacy and protection for user medical information and the ability to interact with Cardiac Designs, LLC technicians and engineers, as well as with their own caregivers. The ECG Check Model ECG01-4S is intended for users that seek to manage their heart rate and rhythms over long periods of time.
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