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

    ASSISTO Universal Applicator Clamping Device

    K Number: K201279 · Decision Jul 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    ASSISTO Universal Applicator Clamping Device
    K Number
    K201279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geomed Medizin-Technik GmbH & Co. KG
    Date Received
    May 13, 2020
    Decision Date
    July 10, 2020
    Product Code
    JAQ
    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
    JAQ System, Applicator, Radionuclide, Remote-Controlled

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    Other Clearances by Geomed Medizin-Technik GmbH & Co. KG

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