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510(k) Data Aggregation

    K Number
    K973267
    Device Name
    TTM5000 TELEPHONIC EKG MONITOR
    Manufacturer
    Date Cleared
    1998-01-29

    (153 days)

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

    HDS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TTM5000 is a fully featured, non-invasive 9 Volt battery operated ECG (Electrocardiogram) Event Recorder. The intended use of TTM5000 is to record electrical heart signals (Electrocardiogram) of the patient. The recorded analog data can be transmitted over the telephone lines to a transtelephonic ECG receiving system. it is used mainly by Cardiologists and Internists to detect transient arrhythmias. The device is also called arrhythmia recorder.
    Device Description
    TTM5000 Telephonic EKG Monitor is a hand held, 9 Volt battery operated ECG Event Recorder.
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