BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    MERLIN E-MASK

    K Number: K031397 · Decision Jul 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    2
    Review Days
    454

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    Basic Information

    Device Name
    MERLIN E-MASK
    K Number
    K031397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Merlin Medical Limited
    Date Received
    May 2, 2003
    Decision Date
    July 29, 2004
    Product Code
    CBP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBP Valve, Non-Rebreathing

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    Other Clearances by Merlin Medical Limited

    K Number Device Name
    K031395 MERLIN RESUSCITATOR