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510(k) Data Aggregation

    K Number
    K991853
    Device Name
    INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
    Date Cleared
    1999-10-25

    (146 days)

    Product Code
    Regulation Number
    882.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computer-based testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.
    Device Description
    The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computerbased testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.
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    K Number
    K990585
    Device Name
    INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
    Date Cleared
    1999-05-17

    (83 days)

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

    IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Interacoustics AT22t Automatic Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.
    Device Description
    The Interacoustics AT22t Automatic Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.
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    K Number
    K990652
    Device Name
    INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
    Date Cleared
    1999-05-17

    (77 days)

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

    IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Interacoustics AZ26 Clinical Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.
    Device Description
    Our device, the Model AZ26 Clinical Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.
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    K Number
    K983832
    Device Name
    INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
    Date Cleared
    1999-01-25

    (87 days)

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

    IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Interacoustics MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of now sible otologic disorders.
    Device Description
    Our device, the Model MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of possible otologic disorders.
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    K Number
    K982249
    Device Name
    INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
    Date Cleared
    1998-08-07

    (42 days)

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

    IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Interacoustics Model AD229 Diagnostic Audiometer is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. Because of its master hearing aid capability this device is also indicated for simulating a hearing aid during audiometric testing thus it may help in the selection and adjustment of a patient's hearing aid.
    Device Description
    The Interacoustics Model AD229 Diagnostic Audiometer is an electroacoustic device that produces controlled levels of test tones and signals. The unit employs digital readouts and includes an external power supply that contains an isolation transformer. The tones and sound signals are directed to the patient by means of the following transducers: TDH39 Audiometric Headset (standard); EAR-Tone 3A Insert Phones (optional); and B71 Bone Conductor (standard). This device also has master hearing aid capability and utilizes either the TDH39 Headset or the Ear-Tone 3A Insert Phones for the acoustical outputs.
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    K Number
    K981327
    Device Name
    INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
    Date Cleared
    1998-05-11

    (28 days)

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

    IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Interacoustics Model AD226 Diagnostic Audiometer is indicated for use in The Interacoustics Model AB220 Diagnostic and assisting in the diagnosis of possible otologic disorders.
    Device Description
    The interacoustics Model AD226 Diagnostic Audiometer is an electroacoustics instrument that produces and as a diagnectic hostring electroacousiic test instrument until processible stallegic disording tones and signals intended for acc in conductions of possible otologic disorders.
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