BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

    K Number: K152670 · Decision Jan 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    96
    Review Days
    127

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    Basic Information

    Device Name
    DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
    K Number
    K152670
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medos International SARL
    Date Received
    September 17, 2015
    Decision Date
    January 22, 2016
    Product Code
    GWM
    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
    GWM Device, Monitoring, Intracranial Pressure

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