BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Hearing Healthcare Pro

    K Number: K183201 · Decision Mar 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    2
    Review Days
    107

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    Basic Information

    Device Name
    Hearing Healthcare Pro
    K Number
    K183201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Db Diagnostic Systems, Inc.
    Date Received
    November 19, 2018
    Decision Date
    March 6, 2019
    Product Code
    ETY
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETY Tester, Auditory Impedance

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    Other Clearances by Db Diagnostic Systems, Inc.

    K Number Device Name
    K171038 Hearing Healthcare Pro