FDA 510(k)

您好，eyes® 生物插頭

K 號：K241229 · 2024-06-28

決定日期2024-06-28

產品代碼LZU

決定相當於

器材摘要

Hello,eyes® BIO Plug is the device name listed in this FDA 510(k) record. The listed applicant is Bio Optics Co., Ltd.. It received FDA 510(k) clearance on 2024-06-28 under 510(k) number K241229. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

常見問題

What is the Hello,eyes® BIO Plug?

Hello,eyes® BIO Plug is a medical device that received FDA 510(k) clearance on 2024-06-28. The listed applicant is Bio Optics Co., Ltd.. The 510(k) number is K241229.

When did Hello,eyes® BIO Plug receive FDA 510(k) clearance?

Hello,eyes® BIO Plug received FDA 510(k) clearance on 2024-06-28, under 510(k) number K241229.

Who is the listed applicant for Hello,eyes® BIO Plug?

The FDA 510(k) record lists Bio Optics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hello,eyes® BIO Plug?

The FDA product code for Hello,eyes® BIO Plug is LZU.

相關器械（代碼：LZU）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LZU）

官方來源