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510(k) Data Aggregation

    K Number
    K092244
    Device Name
    MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
    Manufacturer
    DIAGNOSTIC GROUP LLC
    Date Cleared
    2010-03-01

    (216 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 MA61, MA62, and MA63, family of audiometers are a portable line of devices ranging from a one and a half channel, to a full two-channel, air, bone, and speech audiometer. These audiometers are used to screen, test, and diagnose hearing loss.

    Device Description

    The MA61, MA62, and MA63, family of audiometers are a portable line of devices ranging from a one and a half channel, to a full two-channel, air, bone, and speech audiometer.

    AI/ML Overview

    This is a regulatory letter from the FDA regarding an audiometer device (MA61, MA62, MA63). It is not a study that contains information about acceptance criteria, device performance, sample sizes, expert ground truth, or adjudication methods for an AI/ML powered device.

    Therefore, I cannot extract the requested information from the provided text. The document pertains to the FDA's substantial equivalence determination for a medical device and does not contain the kind of study details you are asking for.

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