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510(k) Data Aggregation

    K Number
    K042849
    Device Name
    CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
    Manufacturer
    CARDIOBIOMEDICAL CORPORATION
    Date Cleared
    2005-01-13

    (90 days)

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

    CARDIOBIOMEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cardio Spectrum Diagnostic System intended to be used as an aid to diagnosis by means of analysis of the ECG waveform in the frequency domain (power spectral estimate).
    Device Description
    Not Found
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