FDA 510(k)

眼優先

K 號：K190786 · 2019-04-11

決定日期2019-04-11

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

Eye Prime is the device name listed in this FDA 510(k) record. The listed applicant is Ellex Medical Pty, Ltd.. It received FDA 510(k) clearance on 2019-04-11 under 510(k) number K190786. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Eye Prime?

Eye Prime is a medical device that received FDA 510(k) clearance on 2019-04-11. The listed applicant is Ellex Medical Pty, Ltd.. The 510(k) number is K190786.

When did Eye Prime receive FDA 510(k) clearance?

Eye Prime received FDA 510(k) clearance on 2019-04-11, under 510(k) number K190786.

Who is the listed applicant for Eye Prime?

The FDA 510(k) record lists Ellex Medical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eye Prime?

The FDA product code for Eye Prime is IYO.

其他以 Ellex Medical Pty, Ltd. 為申請人之記錄

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官方來源

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