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510(k) Data Aggregation

    K Number
    K171265
    Device Name
    Otowave 302 Portable Tympanometer
    Manufacturer
    Amplivox Ltd
    Date Cleared
    2017-07-28

    (88 days)

    Product Code
    NAS
    Regulation Number
    874.1090
    Why did this record match?
    Product Code :

    NAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K150163
    Device Name
    Otowave 202 Portable Tympanometer
    Manufacturer
    AMPLIVOX, LTD.
    Date Cleared
    2015-04-23

    (87 days)

    Product Code
    NAS, AUD
    Regulation Number
    874.1090
    Why did this record match?
    Product Code :

    NAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amplivox Otowave 202 is designed for use by trained operators (audiologists, general practitioners, hearing aid dispensers, and child health professionals) in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders in the general population associated with the functioning of the middle ear. The instrument performs two types of measurement: Tympanometry is used to measure the tympanic membrane and middle ear at a fixed frequency over a range of pressures. Reflex tests are used to measure stapedial reflexes. The Otowave measures ipsilateral reflexes and, when selected, reflex measurement is automatically carried out after a tympanogram is taken.
    Device Description
    The Otowave 202 relies heavily on long-established practice in the clinical area of middle-ear measurements, and implements tympanometer functionality in a small desk-top device that may be powered from the mains (via a d.c. adapter) or by internal batteries. Stimuli are applied to the patient by means of a probe mounted on a flexible connecting lead for ease of use (especially with neonates) and additional contralateral stimuli are available if required via a separate plug-in transducer. Operation is via an intuitive menu-driven user interface, with test data displayed on the integral screen and capable of download to a PC via a USB connection and to a printer via an infrared communications (IrDA) interface. Tympanometers work by measuring the admittance of the tympanic membrane while the pressure in the ear canal is varied. The admittance is at a maximum when the air pressure across the tympanic membrane is balanced.
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