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

    MODEL FS1

    K Number: K790481 · Decision Apr 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    60
    Review Days
    26

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    Basic Information

    Device Name
    MODEL FS1
    K Number
    K790481
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3330
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Starkey Laboratories, Inc.
    Date Received
    March 8, 1979
    Decision Date
    April 3, 1979
    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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