BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    STOCKERT NEURO N50, MODEL12267

    K Number: K070336 · Decision Jun 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    5
    Review Days
    129

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    Basic Information

    Device Name
    STOCKERT NEURO N50, MODEL12267
    K Number
    K070336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stockert GmbH
    Date Received
    February 5, 2007
    Decision Date
    June 14, 2007
    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 Stockert GmbH

    K Number Device Name
    K070134 MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
    K061983 STIMUPLEX PEN
    K052313 STIMUPLEX HNS-12, MODEL 4892098
    K003983 STIMUPLEX HNS-11