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

    SilentCloud

    K Number: K221125 · Decision Jan 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    1
    Review Days
    261

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    Basic Information

    Device Name
    SilentCloud
    K Number
    K221125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3400
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aureliym GmbH
    Date Received
    April 18, 2022
    Decision Date
    January 4, 2023
    Product Code
    KLW
    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
    KLW Masker, Tinnitus

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