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

    OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP

    K Number: K021869 · Decision Jul 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    8
    Review Days
    25

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    Basic Information

    Device Name
    OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
    K Number
    K021869
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diros Technology, Inc.
    Date Received
    June 6, 2002
    Decision Date
    July 1, 2002
    Product Code
    GXD
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXD Generator, Lesion, Radiofrequency

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    Other Clearances by Diros Technology, Inc.

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    K110593 OWL RF PROBES
    K093185 OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
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