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510(k) Data Aggregation

    K Number
    K981142
    Device Name
    MAICO MA53
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1998-04-22

    (23 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MAICO MA53

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for an audiometer (Maico MA53) from 1998. It does not contain information about specific acceptance criteria or study results because, for 510(k) clearances, the primary mechanism for demonstrating safety and effectiveness is substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as might be seen for PMA submissions or more recent AI/ML device clearances.

    Therefore, I cannot provide the requested information based on this document. The document essentially states that the device is substantially equivalent to devices marketed before 1976 and is cleared for marketing.

    To answer your request, I would need a different type of document, such as a summary of safety and effectiveness (SSE) for a more recent device, especially one involving AI/ML components, or a PMA (Premarket Approval) document.

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