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

    ISIS MER SYSTEM/ELEKTA MER SYSTEM

    K Number: K042208 · Decision Mar 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    57
    Applicant Total
    10
    Review Days
    214

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    Basic Information

    Device Name
    ISIS MER SYSTEM/ELEKTA MER SYSTEM
    K Number
    K042208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inomed Medizintechnik GmbH
    Date Received
    August 16, 2004
    Decision Date
    March 18, 2005
    Product Code
    GZL
    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
    GZL Electrode, Depth

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