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510(k) Data Aggregation

    K Number
    K970436
    Device Name
    E-READER
    Manufacturer
    NATURAL HERBAL PRODUCTS, INC.
    Date Cleared
    1997-08-15

    (191 days)

    Product Code
    GZO,84G
    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

    Galvanic Skin Resistance Measurement

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "E-Reader". It only indicates that the device is a "Galvanic Skin Resistance Measurement" device and is substantially equivalent to a pre-amendment device.

    This document does not contain any information regarding:

    • Acceptance criteria or reported device performance
    • Details of any study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details).

    Therefore, I cannot fulfill your request for a description of acceptance criteria and the study that proves the device meets them based on the provided text.

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