BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PENASE

    K Number: K833888 · Decision Jan 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    67
    Applicant Total
    93
    Review Days
    55

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    Basic Information

    Device Name
    PENASE
    K Number
    K833888
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2560
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Oxoid U.S.A., Inc.
    Date Received
    November 9, 1983
    Decision Date
    January 3, 1984
    Product Code
    MDB
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MDB System, Blood Culturing

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