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

    MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM

    K Number: K020281 · Decision Feb 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    9
    Applicant Total
    22
    Review Days
    14

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    Basic Information

    Device Name
    MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
    K Number
    K020281
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ventlab Corp.
    Date Received
    January 28, 2002
    Decision Date
    February 11, 2002
    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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