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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
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving the device meets those criteria. The document is solely a 510(k) clearance letter from the FDA to Clover Hi-Tech, Inc. for their Bio-Cybernetics Cardio-Diagnostic System. It confirms that the device has been found substantially equivalent to a legally marketed predicate device and lists the indications for use.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given document.

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