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510(k) Data Aggregation

    K Number
    K072950
    Device Name
    CYGNUS 12 LEAD ECG MODULE
    Manufacturer
    CYGNUS, LLC
    Date Cleared
    2008-08-22

    (309 days)

    Product Code
    KRE
    Regulation Number
    870.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYGNUS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - The device is for prescription use only. - The device is intended to be used in a clinic or hospital. - The device is intended for use by the physician (or his/her representative), not by the patient, although one intended use is to record the patient's 12-lead ECG. - The device is intended for use as a : Fully functional ECG/heart rate monitoring system for clinical use. Pacemaker Detection and measurement. A TTM (trans-telephonic) Receiving Station. - In TTM mode, the device is intended for use with landline analog and digital PBX telephone systems only. It is not intended to be used with wireless networks.
    Device Description
    Cygnus 12 Lead/TTM ECG module is a fully functional ECG and Pacemaker monitoring system that is powered through a PC USB (Universal Serial Bus) port. Four general parts could be distinguished in the Cygnus 12 Lead/TTM ECG module: - An analog front end. - Digital Signal Processing USB Interface Unit. - TTM Interface for analog phone lines. - TTM Interface for digital phones. The module measures the 12 standard ECG leads on the isolated input, and is capable of acting as an ECG Receiving Station over the phone line for ECG and pacemaker encoded signal with Frequency Modulation (FM).
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