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FDA 510(k)

FAQ™ (302)

K号: K242747 · 2024-12-11

申请人Foreo, Inc.
决定日期2024-12-11
产品代码OAP
咨询委员会PM 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

FAQ™ (302) is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2024-12-11 under 510(k) number K242747. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FAQ™ (302)?

FAQ™ (302) is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Foreo, Inc.. The 510(k) number is K242747.

When did FAQ™ (302) receive FDA 510(k) clearance?

FAQ™ (302) received FDA 510(k) clearance on 2024-12-11, under 510(k) number K242747.

Who is the listed applicant for FAQ™ (302)?

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

What is the FDA product code for FAQ™ (302)?

The FDA product code for FAQ™ (302) is OAP.

列明Foreo, Inc.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:OAP)

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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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。

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