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510(k) Data Aggregation
K Number
K171411Device Name
IRRIS (Infra-Red-Red Intubation System)
Manufacturer
Date Cleared
2018-01-12
(242 days)
Product Code
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
A.R Guide In Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IRRIS is intended for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices.
Device Description
The IRRIS is designed for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices. The IRRIS is a non-invasive electronic illumination device. The device transmits light of a specific wavelength (near infra-red) to the underlying tissues. The light enables to illuminate the trachea of the patient, so it can be distinguished from other tissues while using video assisted devices (video-laryngoscopes).
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