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510(k) Data Aggregation

    K Number
    K031397
    Device Name
    MERLIN E-MASK
    Manufacturer
    MERLIN MEDICAL LIMITED
    Date Cleared
    2004-07-29

    (454 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERLIN MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Merlin Medical Limited Merlin E-Mask Air Pulmonary Resuscitator is indicated for mouth to mask ventilation of a non-breathing adult and child weighing over 30 kgs.
    Device Description
    Not Found
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERLIN MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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