FDA 510(k)

Eyer 视网膜相机 NM-STD

K号: K221329 · 2023-02-22

决定日期2023-02-22

产品代码HKI

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决定实质等同

器械摘要

Eyer Retinal Camera NM-STD is the device name listed in this FDA 510(k) record. The listed applicant is Phelcom Technologies. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K221329. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Eyer Retinal Camera NM-STD?

Eyer Retinal Camera NM-STD is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Phelcom Technologies. The 510(k) number is K221329.

When did Eyer Retinal Camera NM-STD receive FDA 510(k) clearance?

Eyer Retinal Camera NM-STD received FDA 510(k) clearance on 2023-02-22, under 510(k) number K221329.

Who is the listed applicant for Eyer Retinal Camera NM-STD?

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

What is the FDA product code for Eyer Retinal Camera NM-STD?

The FDA product code for Eyer Retinal Camera NM-STD is HKI.

列明Phelcom Technologies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。

K251353Eyer 2

官方来源

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