Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K013827
    Manufacturer
    Date Cleared
    2002-05-21

    (183 days)

    Product Code
    Regulation Number
    874.3400
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TST Suppressor 1000 device is selected sound tracks delivered to the ear by a Standard digital audio player and using an air-conduction earpiece or headphone type transadeers: The 151 Saperience relief of their Tinnitus symptoms when using the Hintus Sunerers who expending fair to excellent hearing in the frequency range 100 device and vince out. Pan there is no more than 35 dB loss in the affected ear in that frequency range and where their Tinnitus is unilateral or bilateral.

    The TST Suppressor 1000 is for home use.

    Each TST Suppressor 1000 device may be used to suppress the symptoms of tinnitus Eden 191 Suppresser Loigital audio player, using commercially available earphones or headphones.

    Device Description

    The TST Suppressor 1000 device is selected sound tracks delivered to the ear by a Standard digital audio player and using an air-conduction earpiece or headphone type transadeers.

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the TST Suppressor 1000, a tinnitus masker. It includes the indications for use but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on detailed performance study results.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1