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

    ADMS MULTIPLANE RECTAL PROBE

    K Number: K895359 · Decision Nov 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    2
    Review Days
    86

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    Basic Information

    Device Name
    ADMS MULTIPLANE RECTAL PROBE
    K Number
    K895359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Avalon Technology Corp.
    Date Received
    August 28, 1989
    Decision Date
    November 22, 1989
    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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