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510(k) Data Aggregation

    K Number
    K112268
    Device Name
    CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
    Manufacturer
    CODAN US CORP.
    Date Cleared
    2012-03-19

    (224 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CODAN SAFEFEED ENTERAL FEEDING RESERVOIR

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

    The CODAN™ SafeFeed Enteral Feeding Reservoir is intended for the storage and delivery of liquid medication, formula, and breast milk.

    Device Description

    The CODAN™ SafeFeed Enteral Feeding Reservoir is disposable and for single patient use only.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the CODAN™ SafeFeed Enteral Feeding Reservoir. It outlines the regulatory approval of the device and its intended use. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).

    Therefore, I cannot fulfill your request for this specific information based on the provided document. The document focuses on regulatory approval and substantial equivalence to a predicate device, not detailed performance studies.

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