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

    PENSIL TRAUMA, MODEL WWS6100

    K Number: K993962 · Decision Dec 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    9
    Review Days
    57

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    Basic Information

    Device Name
    PENSIL TRAUMA, MODEL WWS6100
    K Number
    K993962
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wuestec Medical, Inc.
    Date Received
    October 25, 1999
    Decision Date
    December 21, 1999
    Product Code
    KPR
    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
    KPR System, X-Ray, Stationary

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