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

    MODEL BION 1/TYPE 1084T CAR IONIZER

    K Number: K851094 · Decision Jun 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    14
    Review Days
    92

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    Basic Information

    Device Name
    MODEL BION 1/TYPE 1084T CAR IONIZER
    K Number
    K851094
    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
    March 19, 1985
    Decision Date
    June 19, 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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