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510(k) Data Aggregation

    K Number
    K070312
    Device Name
    EARCHECK ACOUSTIC REFLECTOMETER
    Manufacturer
    INNOVIA MEDICAL, LLC
    Date Cleared
    2007-03-02

    (29 days)

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

    INNOVIA MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EarCheck Acoustic Reflectometer is an advanced medical instrument which accurately deflects the presence of middle ear fluid (i.e., otitis media with effusion) that may be associated with acute ear infection. The device is intended to assist parents in determining when to seek medical attention. The instrument is designed for use in the home by parents and other caregivers on children from 6 months to young adult.
    Device Description
    EarCheck Acoustic Reflectometer is an advanced medical instrument.
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