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

    BE PLUS / AURA-LTM64 AMPLIFIER

    K Number: K053606 · Decision Jan 24, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    13
    Review Days
    28

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    Basic Information

    Device Name
    BE PLUS / AURA-LTM64 AMPLIFIER
    K Number
    K053606
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eb Neuro S.P.A.
    Date Received
    December 27, 2005
    Decision Date
    January 24, 2006
    Product Code
    GWL
    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
    GWL Amplifier, Physiological Signal

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