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FDA 510(k)

Cyware 4H和Cysart 4H

K号: K221796 · 2022-12-30

申请人Abys Medical
决定日期2022-12-30
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

Cyware 4H and Cysart 4H is the device name listed in this FDA 510(k) record. The listed applicant is Abys Medical. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K221796. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cyware 4H and Cysart 4H?

Cyware 4H and Cysart 4H is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Abys Medical. The 510(k) number is K221796.

When did Cyware 4H and Cysart 4H receive FDA 510(k) clearance?

Cyware 4H and Cysart 4H received FDA 510(k) clearance on 2022-12-30, under 510(k) number K221796.

Who is the listed applicant for Cyware 4H and Cysart 4H?

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

What is the FDA product code for Cyware 4H and Cysart 4H?

The FDA product code for Cyware 4H and Cysart 4H is LLZ.

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。

相关器械(代码:LLZ)

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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