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

    RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1

    K Number: K922570 · Decision Aug 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    41
    Review Days
    66

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    Basic Information

    Device Name
    RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1
    K Number
    K922570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3320
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Resound Corp.
    Date Received
    June 1, 1992
    Decision Date
    August 6, 1992
    Product Code
    EPF
    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
    EPF Hearing Aid, Group And Auditory Trainer

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