FDA 510(k)

Claritag 高级

K号: K222356 · 2023-05-18

决定日期2023-05-18

产品代码GEH

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决定实质等同

器械摘要

Claritag Advanced is the device name listed in this FDA 510(k) record. The listed applicant is Dgi Technologies. It received FDA 510(k) clearance on 2023-05-18 under 510(k) number K222356. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Claritag Advanced?

Claritag Advanced is a medical device that received FDA 510(k) clearance on 2023-05-18. The listed applicant is Dgi Technologies. The 510(k) number is K222356.

When did Claritag Advanced receive FDA 510(k) clearance?

Claritag Advanced received FDA 510(k) clearance on 2023-05-18, under 510(k) number K222356.

Who is the listed applicant for Claritag Advanced?

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

What is the FDA product code for Claritag Advanced?

The FDA product code for Claritag Advanced is GEH.

列明Dgi 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。

K190747Claritag

相关器械（代码：GEH）

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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官方来源

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