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FDA 510(k)

ACE Cannula

K号: K242741 · 2025-01-08

决定日期2025-01-08
产品代码FMI
咨询委员会医疗设备监管文本翻译如下: HO 请注意,由于您没有提供具体的医疗设备监管文本内容,以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

ACE Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical Industry Co., Ltd.. It received FDA 510(k) clearance on 2025-01-08 under 510(k) number K242741. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ACE Cannula?

ACE Cannula is a medical device that received FDA 510(k) clearance on 2025-01-08. The listed applicant is Ace Medical Industry Co., Ltd.. The 510(k) number is K242741.

When did ACE Cannula receive FDA 510(k) clearance?

ACE Cannula received FDA 510(k) clearance on 2025-01-08, under 510(k) number K242741.

Who is the listed applicant for ACE Cannula?

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

What is the FDA product code for ACE Cannula?

The FDA product code for ACE Cannula is FMI.

相关临床试验

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相关器械(代码:FMI)

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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