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510(k) Data Aggregation

    K Number
    K964680
    Device Name
    COMFORTAID HEARING AID
    Date Cleared
    1997-01-24

    (63 days)

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

    ETHICAL HEARING INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    The design follows traditional principles of operation for Hearing Aids. The device is manufactured and assembled with equivalent manufacturing practices and performance guidelines.
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    K Number
    K962012
    Device Name
    ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
    Date Cleared
    1996-08-21

    (90 days)

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

    ETHICAL HEARING INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    Wizard Loudness Growth Tester
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