BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ENT EM

    K Number: K223734 · Decision Apr 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    36
    Applicant Total
    135
    Review Days
    135

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    Basic Information

    Device Name
    ENT EM
    K Number
    K223734
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brainlab AG
    Date Received
    December 13, 2022
    Decision Date
    April 27, 2023
    Product Code
    PGW
    Advisory Committee
    Neurology
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PGW Ear, Nose, And Throat Stereotaxic Instrument

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