FDA 510(k)

Blue Eye

K号: K241591 · 2024-07-03

决定日期2024-07-03

产品代码PLL

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决定实质等同

器械摘要

Blue Eye is the device name listed in this FDA 510(k) record. The listed applicant is The Standard Co., Ltd.. It received FDA 510(k) clearance on 2024-07-03 under 510(k) number K241591. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Blue Eye?

Blue Eye is a medical device that received FDA 510(k) clearance on 2024-07-03. The listed applicant is The Standard Co., Ltd.. The 510(k) number is K241591.

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

Blue Eye received FDA 510(k) clearance on 2024-07-03, under 510(k) number K241591.

Who is the listed applicant for Blue Eye?

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

What is the FDA product code for Blue Eye?

The FDA product code for Blue Eye is PLL.

列明The Standard Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K220434Blue Eye (TS-905)

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

列明The Standard Co., Ltd.为申报人的其他记录

相关器械（代码：PLL）

官方来源