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FDA 510(k)

Solea

K号: K221761 · 2022-09-14

申请人Convergent Dental, Inc.
决定日期2022-09-14
产品代码NVK
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Solea is the device name listed in this FDA 510(k) record. The listed applicant is Convergent Dental, Inc.. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K221761. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Solea?

Solea is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Convergent Dental, Inc.. The 510(k) number is K221761.

When did Solea receive FDA 510(k) clearance?

Solea received FDA 510(k) clearance on 2022-09-14, under 510(k) number K221761.

Who is the listed applicant for Solea?

The FDA 510(k) record lists Convergent Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solea?

The FDA product code for Solea is NVK.

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相关器械（代码：NVK）

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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