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510(k) Data Aggregation
K Number
K130760Device Name
ELECTROSURGICAL GENERATOR
Date Cleared
2013-09-16
(180 days)
Product Code
Regulation Number
878.4400Why 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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