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

    BE PLUS LTM AMPLIFIER GWI AMPLIFIER

    K Number: K121996 · Decision Aug 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    13
    Review Days
    25

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    Basic Information

    Device Name
    BE PLUS LTM AMPLIFIER GWI AMPLIFIER
    K Number
    K121996
    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
    July 9, 2012
    Decision Date
    August 3, 2012
    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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    Other Clearances by Eb Neuro S.P.A.

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    K142064 GALILEO NT
    K133517 NEMUS 2 SYSTEM
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    K073415 NEMUS SYSTEM; NEMUS PC PERIPHERAL
    K061996 SANDMAN POCKET
    K053606 BE PLUS / AURA-LTM64 AMPLIFIER
    K041198 NIC36 AMPLIFIER
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