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

    VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM

    K Number: K904328 · Decision Jun 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    22
    Applicant Total
    14
    Review Days
    271

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    Basic Information

    Device Name
    VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM
    K Number
    K904328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1845
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Telediagnostic Systems, Inc.
    Date Received
    September 20, 1990
    Decision Date
    June 18, 1991
    Product Code
    GWK
    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
    GWK Conditioner, Signal, Physiological

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