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

    ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.

    K Number: K874861 · Decision May 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    47
    Applicant Total
    24
    Review Days
    166

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    Basic Information

    Device Name
    ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.
    K Number
    K874861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Acuson Computed Sonography
    Date Received
    November 27, 1987
    Decision Date
    May 11, 1988
    Product Code
    DPT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPT Probe, Blood-Flow, Extravascular

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    Other Clearances by Acuson Computed Sonography

    K Number Device Name
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    K874363 ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.
    K874922 ACUSON TRANSPERINEAL NEEDLE GUIDE
    K874860 ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.
    K871506 ACUSON L538 TRANSDUCER
    K871416 AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER
    K871239 ACUSON PHYSIOLOGICAL CONTROL MODULE
    K864578 ACUSON TV519 TRANSDUCER
    K863236 ACUSON S519B TRANSDUCER
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