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510(k) Data Aggregation

    K Number
    K031395
    Device Name
    MERLIN RESUSCITATOR
    Manufacturer
    MERLIN MEDICAL LIMITED
    Date Cleared
    2004-07-16

    (441 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Merlin Resuscitators are manual resuscitators incorporating a bag and valve. They are intended for use in providing artificial respiration to patients suffering from respiratory distress. The infant model is intended for patients weighing between 5 and 12 kg, the child model for patients weighing between 12 and 30 kg, and the adult model is intended for patients weighing more than 30 kg. The Merlin Resuscitator is available in reusable and in disposable models.

    Device Description

    Manual resuscitators incorporating a bag and valve.

    AI/ML Overview

    This document is a 510(k) premarket notification letter for the Merlin Resuscitator. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. It confirms the FDA's determination of substantial equivalence to a predicate device. Therefore, I cannot provide the requested information based on this input.

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