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510(k) Data Aggregation

    K Number
    K961827
    Device Name
    IN-THE-EAR
    Manufacturer
    QUALITONE
    Date Cleared
    1996-07-03

    (51 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUALITONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    The design follows traditional principles of operation for hearing aid instruments. This device is manufactured and assembled with equivalent manufacturing practices and performance guidelines. Performance of this instrument meets requirements specified by ANSI S-3.22 1987. User controls and methods are similar to other products currently on the market. Sound processing for this instrument is also similar to devices presently marketed by Qualitone.
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    K Number
    K955466
    Device Name
    DYNAMEQ-II OPTION
    Manufacturer
    QUALITONE
    Date Cleared
    1996-02-13

    (75 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUALITONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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