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

    ULTRASOUND GENERATOR MODLE 2270

    K Number: K920235 · Decision Dec 7, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    13
    Applicant Total
    142
    Review Days
    325

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    Basic Information

    Device Name
    ULTRASOUND GENERATOR MODLE 2270
    K Number
    K920235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4480
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    January 17, 1992
    Decision Date
    December 7, 1992
    Product Code
    FEO
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FEO Lithotriptor, Ultrasonic

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