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

    VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER

    K Number: K092687 · Decision Nov 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    9
    Applicant Total
    7
    Review Days
    83

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    Basic Information

    Device Name
    VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
    K Number
    K092687
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A Plus Medical
    Date Received
    September 1, 2009
    Decision Date
    November 23, 2009
    Product Code
    NHK
    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
    NHK Resuscitator, Manual, Non Self-Inflating

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    Other Clearances by A Plus Medical

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