FDA 510(k)

Saige-Q

K号: K203517 · 2021-04-16

决定日期2021-04-16

产品代码QFM

咨询委员会RA

决定实质等同

器械摘要

Saige-Q is the device name listed in this FDA 510(k) record. The listed applicant is DeepHealth, Inc.. It received FDA 510(k) clearance on 2021-04-16 under 510(k) number K203517. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Saige-Q?

Saige-Q is a medical device that received FDA 510(k) clearance on 2021-04-16. The listed applicant is DeepHealth, Inc.. The 510(k) number is K203517.

When did Saige-Q receive FDA 510(k) clearance?

Saige-Q received FDA 510(k) clearance on 2021-04-16, under 510(k) number K203517.

Who is the listed applicant for Saige-Q?

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

What is the FDA product code for Saige-Q?

The FDA product code for Saige-Q is QFM.

列明DeepHealth, Inc.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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官方来源

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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。