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

    JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009

    K Number: K970035 · Decision Apr 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    8
    Review Days
    88

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    Basic Information

    Device Name
    JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
    K Number
    K970035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Graham-Field, Inc.
    Date Received
    January 3, 1997
    Decision Date
    April 1, 1997
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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