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510(k) Data Aggregation

    K Number
    K981934
    Device Name
    THE BAGNOLI-4 EMG SYSTEM
    Manufacturer
    DELSYS, INC.
    Date Cleared
    1998-08-31

    (90 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is to be used for biofeedback applications.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the Delsys Inc. Bagnoli-4 EMG System, stating that the device is substantially equivalent to legally marketed predicate devices for biofeedback applications. This document does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

    Therefore, I cannot provide the requested information based on the input document. The letter is a regulatory approval, not a scientific study report.

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