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510(k) Data Aggregation

    K Number
    K040794
    Device Name
    INCUBATOR CAPE
    Manufacturer
    WRAPPED IN COMFORT
    Date Cleared
    2004-06-10

    (73 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 :

    INCUBATOR CAPE

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

    Incubator Capes are designed to cover and enhance the outer appearance of an incubator.

    Device Description

    Incubator Cover (accessory to Incubators)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for an "Incubator Cape." This document does not contain information about acceptance criteria or a study proving device performance as described in your request.

    The letter explicitly states: "we have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to existing devices that it does not require a new study to prove its safety or effectiveness. The purpose of a 510(k) notification is to demonstrate substantial equivalence, not to provide new performance data against specific acceptance criteria.

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

    If you have a different document that details performance studies and acceptance criteria for a medical device, please provide it, and I will do my best to extract the information you need.

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