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

    RIWOLITH 2280 PROBES

    K Number: K931755 · Decision Apr 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    60
    Applicant Total
    142
    Review Days
    372

    Basic Information

    Device Name
    RIWOLITH 2280 PROBES
    K Number
    K931755
    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
    April 8, 1993
    Decision Date
    April 15, 1994
    Product Code
    FFK
    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
    FFK Lithotriptor, Electro-Hydraulic

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