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510(k) Data Aggregation

    K Number
    K992703
    Device Name
    CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
    Manufacturer
    PREMIER HEART, LLC.
    Date Cleared
    2000-03-21

    (222 days)

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

    PREMIER HEART, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cardiotron EKG Multi-Phase Information Analysis System is intended to be used as an aid to diagnosis by means of analysis of the EKG waveform in the frequency domain (power spectral estimate).
    Device Description
    The Cardiotron EKG Multi-Phase Information Analysis System will be available in two models, the basic model system and the remote model system. The basic model system consists of two standard EKG amplifiers and an off-the-shelf analog-to-digital ("A/D") converter, EKG lead wires, a computer, a monitor, and a printer. The remote model system additionally includes a dummy terminal or computer. The EKG amplifiers are supplied by the Fortune, Co. The additional components, which are off-the-shelf products, are unmodified. The computer is programmed with the Company's multi-phase information analysis software.
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