BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    g.HIamp

    K Number: K123255 · Decision Dec 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    63

    Basic Information

    Device Name
    g.HIamp
    K Number
    K123255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G.TEC MEDICAL ENGINEERING GMBH
    Date Received
    October 18, 2012
    Decision Date
    December 20, 2012
    Product Code
    GWL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    GWL Amplifier, Physiological Signal

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    Other Clearances by G.TEC MEDICAL ENGINEERING GMBH

    K Number Device Name
    K060803 G.USBAMP