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510(k) Data Aggregation
K Number
K162034Device Name
OBS Electrosurgical Generator (Model: OBS-350A)
Manufacturer
Date Cleared
2017-01-30
(192 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Baisheng Medical Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Electrosurgical Generator (OBS-350A) is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.
Device Description
The generator is enclosed in a metal and molded plastic enclosure and will have an angled front panel in the display and controls area. The front panel displays and controls will be sealed to facilitate cleaning and minimize the possibility of problems caused by accidental spills. The receptacles for the active electrosurgical accessories will be in a recessed area and will conform to IEC60601-1:2005/(R) 2012 And A1:2012.
Device components: Chassis and Cover, Front panel controls, Power supply board, Microprocessor board, Footswitch board, Interface circuits, Front panel receptacles.
Special features: Three CUT modes (Pure CUT, Blend 1, Blend 2), Three COAG modes (COAG1 (Spray), COAG2 (Forced), COAG3 (Soft)), Two Bipolar modes (Bipolar1 (Macro), Bipolar2 (Micro)), Memory (10 memory Presets), CQMS (contact quality monitoring system), Power ON self diagnostics, PPS (peak power system).
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