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

    Parathyroid Detection (Model PTeye) System

    K Number: DEN170056 · Decision Nov 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    403

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    Basic Information

    Device Name
    Parathyroid Detection (Model PTeye) System
    K Number
    DEN170056
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Aibiomed, Corp.
    Date Received
    September 25, 2017
    Decision Date
    November 2, 2018
    Product Code
    QDF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QDF Parathyroid Autofluorescence Detection Device