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FDA 510(k)

IRRIS（紅外線-紅外線插管系統）

K 號：K171411 · 2018-01-12

申請人A.R Guide IN Medical , Ltd.
決定日期2018-01-12
產品代碼BTR
諮詢委員會AN
決定相當於

器材摘要

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.

常見問題

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.

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