FDA 510(k)

FORUM

K号: K213527 · 2022-08-15

决定日期2022-08-15

产品代码NFJ

咨询委员会RA

决定实质等同

器械摘要

FORUM is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2022-08-15 under 510(k) number K213527. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FORUM?

FORUM is a medical device that received FDA 510(k) clearance on 2022-08-15. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K213527.

When did FORUM receive FDA 510(k) clearance?

FORUM received FDA 510(k) clearance on 2022-08-15, under 510(k) number K213527.

Who is the listed applicant for FORUM?

FDA 510(k)记录显示卡尔蔡司医疗技术股份公司（Carl Zeiss Meditec, AG）为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for FORUM?

The FDA product code for FORUM is NFJ.

列明Carl Zeiss Meditec, AG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。

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