BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BABI PLUS NEONATAL RESUSCITATION BAG

    K Number: K112852 · Decision Jan 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    7
    Review Days
    87

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    Basic Information

    Device Name
    BABI PLUS NEONATAL RESUSCITATION BAG
    K Number
    K112852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A Plus Medical
    Date Received
    October 18, 2011
    Decision Date
    January 13, 2012
    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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    Other Clearances by A Plus Medical

    K Number Device Name
    K110471 BABI PLUS INFANT NASAL CANNULA SYSTEM
    K110383 BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
    K102377 VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0
    K093716 BABI PLUS INFANT NASAL CANNULA SYSTEM
    K092687 VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
    K090317 BABI*PLUS BUBBLE PAP VALVE