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

    BTE HEARING AID MULTIFOCUS

    K Number: K915614 · Decision Jan 24, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    2
    Review Days
    39

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    Basic Information

    Device Name
    BTE HEARING AID MULTIFOCUS
    K Number
    K915614
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Opticon Corp.
    Date Received
    December 16, 1991
    Decision Date
    January 24, 1992
    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 Opticon Corp.

    K Number Device Name
    K780699 EARETTE HEARING AID