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

    7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12

    K Number: K863708 · Decision Mar 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    781
    Review Days
    181

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    Basic Information

    Device Name
    7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12
    K Number
    K863708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Siemens Medical Solutions USA, Inc.
    Date Received
    September 23, 1986
    Decision Date
    March 23, 1987
    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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