BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ESSENZ Patient Monitor

    K Number: K212003 · Decision Nov 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    77
    Applicant Total
    7
    Review Days
    135

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    Basic Information

    Device Name
    ESSENZ Patient Monitor
    K Number
    K212003
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Livanova Deutschland, GmbH
    Date Received
    June 28, 2021
    Decision Date
    November 10, 2021
    Product Code
    DXJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXJ Display, Cathode-Ray Tube, Medical

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