BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇴 Norway

    The BAG manual resuscitator and accessories

    K Number: K251631 · Decision Nov 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    5
    Review Days
    180

    Basic Information

    Device Name
    The BAG manual resuscitator and accessories
    K Number
    K251631
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laerdal Medical AS
    Date Received
    May 28, 2025
    Decision Date
    November 24, 2025
    Product Code
    BTM
    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
    BTM Ventilator, Emergency, Manual (Resuscitator)

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