FDA 510(k)

A-Line 高级

K号: K231635 · 2023-06-06

决定日期2023-06-06

产品代码NJM

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决定实质等同

器械摘要

A-Line Advanced is the device name listed in this FDA 510(k) record. The listed applicant is Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K231635. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the A-Line Advanced?

A-Line Advanced is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Biocetec Co., Ltd.. The 510(k) number is K231635.

When did A-Line Advanced receive FDA 510(k) clearance?

A-Line Advanced received FDA 510(k) clearance on 2023-06-06, under 510(k) number K231635.

Who is the listed applicant for A-Line Advanced?

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

What is the FDA product code for A-Line Advanced?

The FDA product code for A-Line Advanced is NJM.

列明Biocetec 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。

K190871Bio-TackS 正畸迷你植入物 K182193S-Line K163467C-Line 正畸陶瓷托槽

官方来源

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