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510(k) Data Aggregation

    K Number
    K090406
    Device Name
    EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
    Manufacturer
    INTERACOUSTICS AS
    Date Cleared
    2009-07-22

    (155 days)

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

    INTERACOUSTICS AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation, documentation and diagnosis of ear disorders on human beings. EP15/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it well suited for waveform based screening and the manual programmability options allow for comprehensive clinical use ranging from frequency specific threshold test to operating room applications and cochlear implant tests. The EP15 is a basic unit allowing only recording of the Auditory Brainstem Response (ABR), while the EP25 allows recording of the ABR and earlier and later potentials. The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli. Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Neurology specialties, Audiologist and other health professionals concerned with measuring auditory functions.
    Device Description
    The EP15 and EP25 systems measure auditory brainstem responses picked up by skin electrodes and amplified by a pre amplifier. The data acquisition of the ABR recordings takes place from the surface electrodes mounted at specific recording points on the patient. The analogue ABR recordings are amplified in the external preamplifier connected to the electrodes. The amplified analogue ABR recordings are converted into a digital signal in the ADC (Analog to Digital Converter) inside the Eclipse. The digital ABR recordings undergo data processing handled by the PC to improve the ABR-recordings. The ABR-recordings are displayed on the monitor for the operator, for further examination and diagnosis. All ABR recordings are stored on the Laptop / Desktop computer hard drive for later examination and diagnosis.
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    K Number
    K083861
    Device Name
    TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
    Manufacturer
    INTERACOUSTICS AS
    Date Cleared
    2009-04-09

    (106 days)

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

    INTERACOUSTICS AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.
    Device Description
    Titan IMP440 consists of a handheld unit named Titan, Titan Cradle and PC software (Titan Suite and Titan IMP440 module). The measurements are controlled by the handheld unit. Titan IMP440 is going to be offered as 3 configurations that will support screening, diagnostic and clinic users. A license system makes it possible within each configuration to select which functionality the user wants to be incorporated in the system. Titan IMP440 is an impedance product based on a hardware platform named Titan Platform. It uses a cabinet named Titan but may use any other cabinets as long as it meets the requirement of the platform. Other products will in the future be developed to the Titan platform and submitted as required and thereby become a part of the Titan System Family as Titan IMP440. A connection box named Titan Shoulder Box enables different types of accessories to the hardware platform.
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    K Number
    K052562
    Device Name
    ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
    Manufacturer
    INTERACOUSTICS AS
    Date Cleared
    2005-12-23

    (95 days)

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

    INTERACOUSTICS AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation, documentation and the automatic recording of ABR waveforms makes it EP15/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it EF 15/2013 a 2 channon ADA and the manual programmability options well suited for waverom baood occorning and and and and specific threshold test to operating room applications and cochlear implant tests. operating foom applications and over over of the Auditory Brainstem Response The E. 1915 a bacil unk allowing of the ABR and earlier and later potentials. The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli. Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Doll of these byotone are of paist and other health professionals concerned with measuring auditory functions.
    Device Description
    Not Found
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    K Number
    K043219
    Device Name
    AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
    Manufacturer
    INTERACOUSTICS AS
    Date Cleared
    2005-02-04

    (74 days)

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

    INTERACOUSTICS AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AC440 system is intended to be used for the detection and diagnosis of suspected hearing loss. The HIT440 system is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting. These two devices can either be sold individually or together in the same housing. The HIT440 system may also be used with other approved Hearing aid test chambers
    Device Description
    Not Found
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