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510(k) Data Aggregation

    K Number
    K043234
    Device Name
    LIGHT DRAPE
    Manufacturer
    WRAPPED IN COMFORT
    Date Cleared
    2005-05-25

    (184 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIGHT DRAPE

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

    Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.

    Device Description

    Light Drape (accessory to Neonatal Phototherapy Light)

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "Light Drape." This document does not contain any information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... You may, therefore, market the device." This indicates that the FDA has found the device to be substantially equivalent to a predicate device, which means it likely does not require extensive new clinical studies or detailed performance metrics to be established for market approval.

    The "Indications for Use" section (Image/page/2) merely states: "Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures." This is a functional description, not a performance claim that would necessitate specific acceptance criteria or a study with the details requested.

    Therefore, I cannot populate the requested information from the provided document.

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