FDA 510(k)

Braun Aura 9 (6042)

K号: K261977 · 2026-09-25

决定日期2026-09-25

产品代码OHT

咨询委员会SU

决定Substantially Equivalent

器械摘要

Braun Aura 9 (6042) is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K261977. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Braun Aura 9 (6042)?

Braun Aura 9 (6042) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Cyden Limited. The 510(k) number is K261977.

When did Braun Aura 9 (6042) receive FDA 510(k) clearance?

Braun Aura 9 (6042) received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261977.

Who is the listed applicant for Braun Aura 9 (6042)?

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

What is the FDA product code for Braun Aura 9 (6042)?

The FDA product code for Braun Aura 9 (6042) is OHT.

列明Cyden Limited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。

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相关器械（代码：OHT）

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。

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