BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Essence 55SP Large Monitor System

    K Number: K201162 · Decision Aug 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    77
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    Essence 55SP Large Monitor System
    K Number
    K201162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenyang Torch-Bigtide Digital Technology Co., Ltd.
    Date Received
    April 30, 2020
    Decision Date
    August 27, 2020
    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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    Other Clearances by Shenyang Torch-Bigtide Digital Technology Co., Ltd.

    K Number Device Name
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