FDA 510(k)

iCare ST500（TA04）

K号: K241447 · 2024-09-27

决定日期2024-09-27

产品代码HKY

咨询委员会OP 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

iCare ST500 (TA04) is the device name listed in this FDA 510(k) record. The listed applicant is Icare Finland OY. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K241447. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iCare ST500 (TA04)?

iCare ST500 (TA04) is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Icare Finland OY. The 510(k) number is K241447.

When did iCare ST500 (TA04) receive FDA 510(k) clearance?

iCare ST500 (TA04) received FDA 510(k) clearance on 2024-09-27, under 510(k) number K241447.

Who is the listed applicant for iCare ST500 (TA04)?

The FDA 510(k) record lists Icare Finland OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iCare ST500 (TA04)?

The FDA product code for iCare ST500 (TA04) is HKY.

列明Icare Finland OY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。

K220852iCare IC200 K211355iCare HOME2 K200966Icare HOME 眼压计 K190316Icare ic200 K163343Icare HOME 眼压计 K153694Icare ic100

查看所有 7 个设备 →

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。