BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    AMADEO, M-UK1015 (incl. attachments and accessories)

    K Number: K213221 · Decision May 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    90
    Applicant Total
    2
    Review Days
    239

    Basic Information

    Device Name
    AMADEO, M-UK1015 (incl. attachments and accessories)
    K Number
    K213221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W&H Dentalwerk Buermoss GmbH
    Date Received
    September 29, 2021
    Decision Date
    May 26, 2022
    Product Code
    ERL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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