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

    VOROBA PROGRAMMABLE AUDITORY COMPARATOR

    K Number: K860171 · Decision May 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    105

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    Basic Information

    Device Name
    VOROBA PROGRAMMABLE AUDITORY COMPARATOR
    K Number
    K860171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3330
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Voroba Technologies Assoc.
    Date Received
    January 17, 1986
    Decision Date
    May 2, 1986
    Product Code
    KHL
    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
    KHL Hearing Aid, Master

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    Other Clearances by Voroba Technologies Assoc.

    K Number Device Name
    K860170 VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID