BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODEL H58-BEHIND-THE-EAR HEARING INSTR.

    K Number: K790697 · Decision May 1, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    10
    Review Days
    21

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    Basic Information

    Device Name
    MODEL H58-BEHIND-THE-EAR HEARING INSTR.
    K Number
    K790697
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Marcon Hearing Instruments, Inc.
    Date Received
    April 10, 1979
    Decision Date
    May 1, 1979
    Product Code
    ESD
    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
    ESD Hearing Aid, Air-Conduction, Prescription

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    Other Clearances by Marcon Hearing Instruments, Inc.

    K Number Device Name
    K823468 MODEL H 37E
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    K791745 MODEL H44-80 BEHIND THE EAR HEARING
    K791126 MODEL CE-DM-II HEARING INSTRUMENT
    K790870 MODEL H63, BEHIND-THE-EAR
    K790779 MODEL H39C-BEHING-THE-EAR HEARING INSTRU
    K790700 BEHIND-THE-EAR HEARING INSTRUMENT, H56
    K790727 BEHIND-THE-EAR, MODEL H37D
    K790726 BEHIND-THE-EAR HEARING INSTRUMENT, H54