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510(k) Data Aggregation
K Number
K200609Device Name
ENTity WiFi Video Nasopharyngoscope System
Manufacturer
Optim, LLC
Date Cleared
2021-01-13
(310 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
Optim, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ENTity WiFi Video Nasopharyngoscope System is intended to be used for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.
Device Description
The ENTity WiFi Video Nasopharyngoscope System is a complete video nasopharyngoscopy system that includes a rechargeable, battery-powered, flexible videoscope with an integral LED light source and WiFi connectivity; a video processor box that receives WiFi signals from the videoscope and provides HDMI output to a video monitor; image management and user interface software; a battery charger accessory for the videoscope; and an active touchscreen monitor accessory that can be used to view images and/or to communicate with the software user interface. Light generated by the LED light source located in the videoscope handle is transmitted through glass fiber optic bundles to the distal tip of the scope, where it illuminates the anatomy to be examined. A CMOS image sensor (camera chip) located at the distal tip of the videoscope captures still or video images in the form of electrical signals, which are wirelessly transmitted to the ENTity WiFi Video Processor. The video processor incorporates user interface and image management software. Still and/or video images may be viewed on the ENTity WiFi Active Touchscreen Monitor; the touchscreen features on the monitor can also be used to interact with the ENTity WiFi Video Processor.
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K Number
K130489Device Name
ELECTRODE, FLEXIBLE SUCTION COAGULATOR
Manufacturer
OPTIM, LLC.
Date Cleared
2013-04-19
(53 days)
Product Code
FEH
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
OPTIM, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
Device Description
This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.
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