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510(k) Data Aggregation

    K Number
    K992129
    Device Name
    PHAZX VLD-100
    Manufacturer
    PHAZX SYSTEMS, INC.
    Date Cleared
    1999-09-17

    (86 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    measurement of galvanic skin resistance, for biofeedback information

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a 510(k) clearance letter from the FDA for the VLD-100 device and an "Indications for Use" form. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other details about the device's validation study. The letter simply states the device is "substantially equivalent" to predicate devices, which is the basis for 510(k) clearance, but it does not include the performance data that led to this determination.

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