FDA 510(k)

Exo Iris (El2001)

K 號：K222198 · 2022-11-09

決定日期2022-11-09

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Exo Iris (El2001) is the device name listed in this FDA 510(k) record. The listed applicant is Exo Imaging, Inc.. It received FDA 510(k) clearance on 2022-11-09 under 510(k) number K222198. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Exo Iris (El2001)?

Exo Iris (El2001) is a medical device that received FDA 510(k) clearance on 2022-11-09. The listed applicant is Exo Imaging, Inc.. The 510(k) number is K222198.

When did Exo Iris (El2001) receive FDA 510(k) clearance?

Exo Iris (El2001) received FDA 510(k) clearance on 2022-11-09, under 510(k) number K222198.

Who is the listed applicant for Exo Iris (El2001)?

The FDA 510(k) record lists Exo Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exo Iris (El2001)?

The FDA product code for Exo Iris (El2001) is IYN.

其他以 Exo Imaging, Inc. 為申請人之記錄

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K211527Exo 眼睛

相關器械（代碼：IYN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

官方來源

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