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FDA 510(k)

IRRIS (Infra-Red-Red Intubation System)

K-Number: K171411 · 2018-01-12

ApplicantA.R Guide IN Medical , Ltd.
Decision Date2018-01-12
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IRRIS (Infra-Red-Red Intubation System) is a medical device manufactured by A.R Guide IN Medical , Ltd.. It received FDA 510(k) clearance on 2018-01-12 under approval number K171411. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIS (Infra-Red-Red Intubation System)?

IRRIS (Infra-Red-Red Intubation System) is a medical device that received FDA 510(k) clearance on 2018-01-12. It is manufactured by A.R Guide IN Medical , Ltd.. The 510(k) number is K171411.

When was IRRIS (Infra-Red-Red Intubation System) approved by the FDA?

IRRIS (Infra-Red-Red Intubation System) received FDA 510(k) clearance on 2018-01-12, under approval number K171411.

What company makes IRRIS (Infra-Red-Red Intubation System)?

IRRIS (Infra-Red-Red Intubation System) is manufactured by A.R Guide IN Medical , Ltd..

What is the FDA product code for IRRIS (Infra-Red-Red Intubation System)?

The FDA product code for IRRIS (Infra-Red-Red Intubation System) is BTR.

Related Clinical Trials

NCT04043910 Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization COMPLETED NCT07189182 Clinical Evaluation of the Origin Intubation System NOT_YET_RECRUITING

Related Devices (Code: BTR)

K152438ETView VivaSight-SL (TVT) systemEtview , Ltd. K161813Frova Intubating IntroducerWilliam Cook Europe Aps K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. K181880VivaSight-SL (TVT) systemEtview , Ltd. K171917Frova Intubating IntroducerCook Incorporated K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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