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510(k) Data Aggregation

    K Number
    K221125
    Device Name
    SilentCloud
    Manufacturer
    Aureliym GmBH
    Date Cleared
    2023-01-04

    (261 days)

    Product Code
    KLW
    Regulation Number
    874.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aureliym GmBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SilentCloud in combination with a Tinnitus Management Program is a therapeutic software tool for the treatment of chronic subjective tinnitus for home use. The target population for the Universal Tinnitus Management System are adult tinnitus patients over 18 years. The SilentCloud is intended to provide relief from the disturbance of chronic subjective timitus while using the device. The SlientCloud is fitted and programmed by a qualified healthcare professional familiar with timitus treatment.
    Device Description
    Not Found
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