Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K060539
    Device Name
    DPOAE20 , ECLIPSE
    Manufacturer
    INTERACOUSTICS A/S, ASSENS
    Date Cleared
    2006-05-30

    (90 days)

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

    INTERACOUSTICS A/S, ASSENS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli. The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE orobe which is placed in the ear canal. The OAE response from the ear is recorded and orocessed by the Eclipse and the DPOAE20 software and then displayed on the computer screen for evaluation. This is of particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions. The patient group includes all ages and sexes.
    Device Description
    Not Found
    Ask a Question
    K Number
    K050496
    Device Name
    REM440
    Manufacturer
    INTERACOUSTICS A/S, ASSENS
    Date Cleared
    2005-04-29

    (60 days)

    Product Code
    ETW
    Regulation Number
    874.3310
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERACOUSTICS A/S, ASSENS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Thor Platform modules in the same housing.
    Device Description
    REM440, (for use with Thor Platform System Products)
    Ask a Question
    K Number
    K030016
    Device Name
    TEOAE25
    Manufacturer
    INTERACOUSTICS A/S, ASSENS
    Date Cleared
    2003-03-28

    (85 days)

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

    INTERACOUSTICS A/S, ASSENS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TEOAE25 is an accessory to the EP15 or EP25 platform and provides the ability to test the cochlea functions of infants, children and adults in hospitals, nurseries, ENT clinics or audiology offices. It measures the amount of otoacoustic emission (OAE) present in the ear after a stimulus, and it allows a trained operator to get objective information about the cochlea function.
    Device Description
    Not Found
    Ask a Question
    K Number
    K022728
    Device Name
    AUDIOTRAVELLER, MODEL AA222
    Manufacturer
    INTERACOUSTICS A/S, ASSENS
    Date Cleared
    2002-10-11

    (56 days)

    Product Code
    ETY
    Regulation Number
    874.1090
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERACOUSTICS A/S, ASSENS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Interacoustics Audio Traveller AA222 is intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The AA222 is a combination of audiometer and tympanometer, which reduces the amount of equipment necessary.
    Device Description
    The AA222 is a combination of audiometer and tympanometer, which reduces the amount of equipment necessary.
    Ask a Question

    Page 1 of 1