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

    L328 TRANSDUCER

    K Number: K905456 · Decision May 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    37
    Review Days
    175

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    Basic Information

    Device Name
    L328 TRANSDUCER
    K Number
    K905456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Acuson Corp.
    Date Received
    December 4, 1990
    Decision Date
    May 28, 1991
    Product Code
    MAA
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MAA Monitor, Fetal Doppler Ultrasound

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