LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982566
    Device Name
    AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
    Manufacturer
    BAR - ADVANCED CONTROL SYSTEMS LTD.
    Date Cleared
    1998-10-21

    (90 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    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

    The ASAM device is an automated audiometer intended for use in conducting hearing threshold evaluations, by the subject without intervention of a skilled professional.

    Device Description

    Automatic Self-Operated Screening Audiometer (ASAM) Device

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for an Automatic Self-Operated Screening Audiometer Device (ASAM). It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1