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

    DESKREM-1000

    K Number: K943459 · Decision Oct 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    45
    Applicant Total
    60
    Review Days
    95

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    Basic Information

    Device Name
    DESKREM-1000
    K Number
    K943459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3310
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Starkey Laboratories, Inc.
    Date Received
    July 18, 1994
    Decision Date
    October 21, 1994
    Product Code
    ETW
    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
    ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

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