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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
    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 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

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Merlin Medical Limited regarding their Merlin E-Mask. This document does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for device performance. It only states that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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