LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K041031
    Device Name
    CARDIOSTATION-100 (CS-100)
    Manufacturer
    US CLOVER CO.
    Date Cleared
    2005-01-26

    (280 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 CardioStation-100 is intended to be used as an aid to diagnosis by means of analysis of cardiac electrical signals in the frequency domain, the power spectral estimate.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the CardioStation-100 device. While it indicates that the device has been cleared based on substantial equivalence to a predicate device, it does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

    The letter primarily focuses on:

    • Acknowledging the 510(k) premarket notification.
    • Stating that the device is substantially equivalent to legally marketed predicate devices.
    • Outlining the regulatory classification (Class II).
    • Reminding the manufacturer of general controls provisions and other applicable regulations.
    • Stating the intended use of the device.

    Therefore, I cannot provide the requested table and details from this document. The information typically needed to answer these questions would be found in the 510(k) submission itself or a separate clinical study report, which is not part of this clearance letter.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1