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510(k) Data Aggregation

    K Number
    K022596
    Device Name
    BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
    Manufacturer
    CLOVER HI-TECH INC.
    Date Cleared
    2003-01-31

    (179 days)

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

    CLOVER HI-TECH INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bio-Cybernetic Cardio Diagnostic 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
    Not Found
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