BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Neuro Omega System

    K Number: K171581 · Decision Dec 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    57
    Applicant Total
    8
    Review Days
    205

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    Basic Information

    Device Name
    Neuro Omega System
    K Number
    K171581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alpha Omega Engineering , Ltd.
    Date Received
    May 31, 2017
    Decision Date
    December 22, 2017
    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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    Other Clearances by Alpha Omega Engineering , Ltd.

    K Number Device Name
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    K123796 NEURO OMEGA SYSTEM
    K120098 STERILE DISPOSABLES FOR MER
    K052527 NEUROPROBES