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510(k) Data Aggregation
K Number
K163412Device Name
Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
Manufacturer
Girgis Scope LLC
Date Cleared
2017-06-22
(199 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Applicant Name (Manufacturer) :
Girgis Scope LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is indicated to improve direct visualization of larynx and assist in both non-complicated and difficult intubation of unpredictable airway condition.
Device Description
GSV200.DBL is designed to assist in tracheal intubation procedure by direct visualization of laryngeal anatomy in closed position and use movable blade with camera as accessory from different angle in open position. The physical shape of GSV200.DBL is a modification of traditional Macintosh blade similar to Propper flip tip laryngoscope with added movable blade with camera as accessory to provide visualization to insert endotracheal tube.
Girgis Scope Video DBL is designed to use two power sources, one in the stationary handle for fiber optic illumination of the airway and the second in the DVR monitor to illuminate the Larynx for the video camera. Battery chargers, cables to computer and cable to connect to TV screen are accessories included in the kit. The GSV200.DBL is provided non-sterile and is reusable and can be disassembled to provide cleaning and disinfection.
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