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510(k) Data Aggregation

    K Number
    K972419
    Device Name
    TOENNIES NEUROSCREEN SYSTEM
    Manufacturer
    ERICH JAEGER, INC.
    Date Cleared
    1998-04-30

    (307 days)

    Product Code
    IKN
    Regulation Number
    890.1375
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TOENNIES NEUROSCREEN SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Diagnostic electromyography, nerve conduction velocity measurement, evoked response electrical stimulator, evoked response photic stimulator, and evoked response auditory stimulator.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "TOENNIES NEUROSCREEN SYSTEM." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria, device performance, specific study details (like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies.

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

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