BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    MODEL IW17.5A INTRA OPERATIVE TRANSDUCER

    K Number: K904665 · Decision Jan 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    MODEL IW17.5A INTRA OPERATIVE TRANSDUCER
    K Number
    K904665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Kretztechnik AG
    Date Received
    October 15, 1990
    Decision Date
    January 11, 1991
    Product Code
    ITX
    Advisory Committee
    Radiology
    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
    ITX Transducer, Ultrasonic, Diagnostic

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