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

    A SLEEP ASSESSMENT DEVICE

    K Number: K792305 · Decision Dec 20, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    34

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    Basic Information

    Device Name
    A SLEEP ASSESSMENT DEVICE
    K Number
    K792305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Farrall Instruments, Inc.
    Date Received
    November 16, 1979
    Decision Date
    December 20, 1979
    Product Code
    LEL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LEL Device, Sleep Assessment

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