BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇷 Türkiye

    Bioscope Neuromonitor Device

    K Number: K233001 · Decision Dec 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    1
    Review Days
    448

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    Basic Information

    Device Name
    Bioscope Neuromonitor Device
    K Number
    K233001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosys Biyomedikal Muhendislik San. VE Tic. A.S.
    Date Received
    September 22, 2023
    Decision Date
    December 13, 2024
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    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
    ETN Stimulator, Nerve

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