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510(k) Data Aggregation
K Number
K053464Device Name
SERVICE MANAGER SM40SE
Manufacturer
CONMED INTEGRATED SYSTEMS, CANADA, ULC
Date Cleared
2006-06-06
(175 days)
Product Code
FYD
Regulation Number
878.5070Why did this record match?
Applicant Name (Manufacturer) :
CONMED INTEGRATED SYSTEMS, CANADA, ULC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the SM40SE console is to position and manage devices such as medical gas, high and low voltage electrical, communication and accessories such as equipment shelves, drawers, IV poles and smoke evacuation units.
The smoke plume evacuator integrated into the SM40SE is intended for the evacuation and filtration of smoke plume and odor generated during laser or electrosurgery.
Device Description
The SM40SE is a space management custom configured consoles into which a variety of medical devices are integrated including a surgical smoke evacuator.
These SM40SE consoles are suspended from articulated ceiling pendant in general operating rooms, minimally invasive surgery suites and post-anaesthesia care units.
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