LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K963788
    Device Name
    PRIMOFOCUS COMPACT
    Manufacturer
    OTICON CORP.
    Date Cleared
    1996-11-27

    (68 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To amplify and deliver sound to the ear.

    Device Description

    BTE Hearing Aid

    AI/ML Overview

    The provided text describes a 510(k) summary for the "PrimoFocus Compact" BTE Hearing Aid. However, it does not contain any information about acceptance criteria, device performance metrics, or study details as requested in the prompt.

    Therefore, I cannot provide the requested information from the given input. The document is a regulatory submission summary outlining the device's basic features and intended use, not a detailed study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1