LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060189
    Device Name
    PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
    Manufacturer
    IVES EEG SOLUTIONS, INC.
    Date Cleared
    2006-05-30

    (126 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)

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

    The pediatric subdermal wire electrode (pSWE) is intended for temporary recording of EEG in comatose pediatric patients (range: 6 to 21 years) in hospital based Intensive Care Units (ICU).

    The pSWE is a disposable, single use device.

    The pSWE is intended for use in a similar manner to that of a subdermal needle electrode.

    Device Description

    Not Found

    AI/ML Overview

    This document describes a 510(k) premarket notification for a medical device and is a regulatory approval letter. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document only confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for its intended use. It is a registration and approval document, not a clinical trial report or a performance study.

    Therefore, I cannot provide the requested information from the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1