FDA 510(k)

EmbedMed

K号: K220366 · 2022-09-30

决定日期2022-09-30

产品代码DZJ

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决定实质等同

器械摘要

EmbedMed is the device name listed in this FDA 510(k) record. The listed applicant is 3D Lifeprints UK , Ltd.. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K220366. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EmbedMed?

EmbedMed is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is 3D Lifeprints UK , Ltd.. The 510(k) number is K220366.

When did EmbedMed receive FDA 510(k) clearance?

EmbedMed received FDA 510(k) clearance on 2022-09-30, under 510(k) number K220366.

Who is the listed applicant for EmbedMed?

The FDA 510(k) record lists 3D Lifeprints UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EmbedMed?

The FDA product code for EmbedMed is DZJ.

列明3D Lifeprints UK , Ltd.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。

K221943EmbedMed

官方来源

在 FDA 数据库中查看 →

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。