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

    KANIEVSKI SENSORY AID OR DEVICE

    K Number: K843433 · Decision Nov 14, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    KANIEVSKI SENSORY AID OR DEVICE
    K Number
    K843433
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Spectro Industries, Inc.
    Date Received
    September 4, 1984
    Decision Date
    November 14, 1984
    Product Code
    LRA
    Advisory Committee
    Unknown
    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
    LRA Hearing Aid, Tactile

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