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

    Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21

    K Number: K160347 · Decision Mar 3, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    134
    Applicant Total
    9
    Review Days
    24

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    Basic Information

    Device Name
    Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
    K Number
    K160347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qingdao Hisense Medical Equipment Co., Ltd.
    Date Received
    February 8, 2016
    Decision Date
    March 3, 2016
    Product Code
    PGY
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PGY Display, Diagnostic Radiology

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    Other Clearances by Qingdao Hisense Medical Equipment Co., Ltd.

    K Number Device Name
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    K221567 LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
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    K152030 Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
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