FDA 510(k)

Oneday 微型埋入式系统

K号: K222946 · 2023-08-23

决定日期2023-08-23

产品代码DZE

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决定实质等同

器械摘要

Oneday Mini Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Oneday Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-08-23 under 510(k) number K222946. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Oneday Mini Implant System?

Oneday Mini Implant System is a medical device that received FDA 510(k) clearance on 2023-08-23. The listed applicant is Oneday Biotech Co., Ltd.. The 510(k) number is K222946.

When did Oneday Mini Implant System receive FDA 510(k) clearance?

Oneday Mini Implant System received FDA 510(k) clearance on 2023-08-23, under 510(k) number K222946.

Who is the listed applicant for Oneday Mini Implant System?

The FDA 510(k) record lists Oneday Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oneday Mini Implant System?

The FDA product code for Oneday Mini Implant System is DZE.

列明Oneday Biotech Co., 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。

K231753Oneday 埋入式基台

官方来源

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