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

    OZONE GENERATOR

    K Number: K043207 · Decision Nov 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    350

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    Basic Information

    Device Name
    OZONE GENERATOR
    K Number
    K043207
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Infrastructure Water & Process Technologies
    Date Received
    November 19, 2004
    Decision Date
    November 4, 2005
    Product Code
    NII
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NII Disinfectant, Dialysate Delivery System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NII), ordered by most recent decision date.

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