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

    TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)

    K Number: K223108 · Decision Jan 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    96
    Review Days
    111

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    Basic Information

    Device Name
    TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
    K Number
    K223108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medos International SARL
    Date Received
    September 30, 2022
    Decision Date
    January 19, 2023
    Product Code
    OLO
    Advisory Committee
    Neurology
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLO Orthopedic Stereotaxic Instrument

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