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

    ACUSON S228, S519 & L558 TRANSDUCERS

    K Number: K861577 · Decision Jun 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    35
    Applicant Total
    24
    Review Days
    52

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    Basic Information

    Device Name
    ACUSON S228, S519 & L558 TRANSDUCERS
    K Number
    K861577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2960
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Acuson Computed Sonography
    Date Received
    April 28, 1986
    Decision Date
    June 19, 1986
    Product Code
    HGL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGL Transducer, Ultrasonic, Obstetric

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    Other Clearances by Acuson Computed Sonography

    K Number Device Name
    K893863 ACUSON L538 TRANSDUCER
    K874028 ACUSON S328 TRANSDUCER
    K874861 ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.
    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
    Search all 24 clearances from Acuson Computed Sonography →