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510(k) Data Aggregation

    K Number
    K033880
    Device Name
    ELECTRO-LUBE
    Manufacturer
    MECTRA LABS, INC.
    Date Cleared
    2004-03-10

    (86 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K052907,K241055
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking.

    Device Description

    Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking.

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the "Electro-Lube" device. It does not contain any information about acceptance criteria, device performance, or any studies conducted on the device.

    The letter is a regulatory compliance document, stating that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It lists the device's indications for use and general regulatory requirements.

    Therefore, I cannot provide the requested information based on the given input, as it is not present in the document.

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