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510(k) Data Aggregation

    K Number
    K982803
    Device Name
    HEARTLINK, MODEL II
    Manufacturer
    CARDIAC TELECOM CORP.
    Date Cleared
    1998-11-13

    (95 days)

    Product Code
    QYX, DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIAC TELECOM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEARTLink II System is intended to provide cardiac monitoring from a low-risk patient's home a central monitoring facility pursuant to to physician prescription.
    Device Description
    The HEARTLink II System receives and processes radiofrequency encoded transmitted ECG signals on the Tele-Link monitoring unit. Abnormal ECGs and arrhythmias detected by the Tele-Link can be displayed on an optional video display monitor, while being simultaneously transmitted through standard telephone lines to a remote Central Station. The Central Station, located within health care institution or patient monitoring facility, is where an alarm is sounded and the ECG is again displayed for the review of medical personnel. The Central Station system has four dedicated phone lines and can provide remote monitoring of ECG data received from 30 individual Tele-Links. A total of 30 patients can be monitored at one time by a single one Central Station.
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