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510(k) Data Aggregation

    K Number
    K130760
    Device Name
    ELECTROSURGICAL GENERATOR
    Date Cleared
    2013-09-16

    (180 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEIJING JINHENGWEI TECHNOLOGY DEVELOPMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electrosurgical Generator (HV-300A, HV-400) is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.
    Device Description
    The proposed device (HV-400 and HV-300A) is an electrosurgical generator with, monopolar and bipolar, high frequency current isolation outputs. The proposed device is independent equipment, which include generator and accessories. The main components are front panel ( power switch, touchable screen, operation key, indicator, connector for accessories), back panel (volume controller, foot switch interface, power cable outlet and fuse) and inner component (display panel, main board, control board, speaker etc.). The accessories include power cable, III-2 cable and foot switch). The two models of proposed device share appearance, function, accessories, the only difference is the output parameter.
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