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

    MODEL BION 2/TYPE 90 ROOM IONIZER

    K Number: K851358 · Decision Jul 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    51
    Applicant Total
    14
    Review Days
    88

    Basic Information

    Device Name
    MODEL BION 2/TYPE 90 ROOM IONIZER
    K Number
    K851358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5045
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    MEDICOR USA LTD.
    Date Received
    April 4, 1985
    Decision Date
    July 1, 1985
    Product Code
    FRF
    Advisory Committee
    General Hospital
    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
    FRF Cleaner, Air, Medical Recirculating

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