BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    ROSA BRAIN (v3.0.0.5)

    K Number: K172444 · Decision Mar 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    8
    Review Days
    226

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    Basic Information

    Device Name
    ROSA BRAIN (v3.0.0.5)
    K Number
    K172444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtech S.A
    Date Received
    August 14, 2017
    Decision Date
    March 28, 2018
    Product Code
    HAW
    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
    HAW Neurological Stereotaxic Instrument

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    Other Clearances by Medtech S.A

    K Number Device Name
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    K151511 ROSA Spine
    K151359 ROSA Brain
    K092239 ROSA SURGICAL DEVICE, MODEL ROSA 1.1