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

    MODEL H 37E

    K Number: K823468 · Decision Dec 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    10
    Review Days
    11

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    Basic Information

    Device Name
    MODEL H 37E
    K Number
    K823468
    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
    November 22, 1982
    Decision Date
    December 3, 1982
    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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    K790727 BEHIND-THE-EAR, MODEL H37D
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