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510(k) Data Aggregation

    K Number
    K981015
    Device Name
    PALI-TRODE
    Manufacturer
    PREFERRED INSTRUMENTS
    Date Cleared
    1998-06-16

    (90 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREFERRED INSTRUMENTS

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

    The Pali-Trode™ Depth Electrode is indicated where intra-operative, short-term recording of multi-unit neural activity is required.

    Device Description

    Semi-Micro Depth Electrode

    AI/ML Overview

    I am sorry, but the provided text describes a 510(k) clearance letter from the FDA for a device called "Semi-Micro Depth Electrode." This document is a regulatory approval, and it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

    The letter confirms that the device is substantially equivalent to a predicate device and can be marketed. It lists the trade name, regulatory class, product code, and indications for use.

    Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

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