Decision Date2018-01-12
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
IRRIS (Infra-Red-Red Intubation System) is the device name listed in this FDA 510(k) record. The listed applicant is A.R Guide IN Medical , Ltd.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) 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. The listed applicant is A.R Guide IN Medical , Ltd.. The 510(k) number is K171411.
When did IRRIS (Infra-Red-Red Intubation System) receive FDA 510(k) clearance?
IRRIS (Infra-Red-Red Intubation System) received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171411.
Who is the listed applicant for IRRIS (Infra-Red-Red Intubation System)?
The FDA 510(k) record lists A.R Guide IN Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
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 Devices (Code: BTR)
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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.