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

    ACUSON V328 AND C5432 TRANSDUCERS

    K Number: K897151 · Decision Jul 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    37
    Review Days
    189

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    Basic Information

    Device Name
    ACUSON V328 AND C5432 TRANSDUCERS
    K Number
    K897151
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Acuson Corp.
    Date Received
    December 26, 1989
    Decision Date
    July 3, 1990
    Product Code
    JTX
    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
    JTX Transport Systems, Anaerobic

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