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510(k) Data Aggregation

    K Number
    K092111
    Device Name
    ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
    Manufacturer
    Date Cleared
    2009-10-02

    (80 days)

    Product Code
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTOMED AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Entomed SA 201/202/203/204 series of audiometers are screening and diagnostic audiometers used to determine hearing thresholds and assist to diagnose hearing loss. The audiometer can be used on the majority of adults and children (from 4 years of age and upwards). The test person has to be able to understand the basic principles of the test method when explained by the operator.
    Device Description
    The SA 201/202/203/204 audiometers are electroacoustic devices that produces controlled levels of test tones and signals. The SA201/202 are IEC 60645 Type 4 Pure Tone Audiometers and the SA203/204 Diagnostic Audiometers are IEC 60645 Type 3 Audiometers. The SA201/202 are manual pure tone air conduction, screening audiometers. SA202 has the additional capability to perform automatic pure tone audiometry. The SA203/204 are both automatic air and bone conduction audiometers with synchronized masking possibility in order to avoid overhearing to the not tested ear. The SA 204 has the additional capability of using speech-testing. Both can be operated manually if required. All models can be used for determination of hearing thresholds and assist to diagnose hearing loss. All models, 201/202/203/204 have a built-in microphone for easier communication with the test person. Furthermore they all have outputs for TDH39, Sennheiser HDA200 and EARtone 5A insert ear phones. SA203/204 have outputs for B71 Bone Conductor and Free-field system (optional).
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