BEUDAMED
    FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

    EPIC ClearView System

    K Number: DEN150004 · Decision Jul 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    549

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    Basic Information

    Device Name
    EPIC ClearView System
    K Number
    DEN150004
    Device Class
    FDA class 1
    Clearance Type
    Direct
    Regulation Number
    882.1561
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Epic Research & Diagnostics, Inc.
    Date Received
    January 13, 2015
    Decision Date
    July 15, 2016
    Product Code
    PNA
    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
    PNA Evoked Photon Image Capture Device