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

    Oculeve Intranasal Tear Neurostimulator Device

    K Number: DEN160030 · Decision Apr 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    291

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    Basic Information

    Device Name
    Oculeve Intranasal Tear Neurostimulator Device
    K Number
    DEN160030
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    886.5300
    Medical Specialty
    Ophthalmic
    Decision
    Unknown
    Applicant
    Oculeve, Inc.
    Date Received
    July 7, 2016
    Decision Date
    April 24, 2017
    Product Code
    PQJ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PQJ Intranasal Electrostimulation Device