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FDA 510(k)

HeartFocus

K号: K260780 · 2026-06-03

申请人Deski
决定日期2026-06-03
产品代码QJU
咨询委员会RA
决定实质等同

器械摘要

HeartFocus is the device name listed in this FDA 510(k) record. The listed applicant is Deski. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K260780. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HeartFocus?

HeartFocus is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Deski. The 510(k) number is K260780.

When did HeartFocus receive FDA 510(k) clearance?

HeartFocus received FDA 510(k) clearance on 2026-06-03, under 510(k) number K260780.

Who is the listed applicant for HeartFocus?

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

What is the FDA product code for HeartFocus?

The FDA product code for HeartFocus is QJU.

相关临床试验

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。

列明Deski为申报人的其他记录

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相关器械(代码:QJU)

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。

官方来源

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