FDA 510(k)

AirKEE T900

K号: K232642 · 2024-05-23

决定日期2024-05-23

产品代码FRA

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

AirKEE T900 is the device name listed in this FDA 510(k) record. The listed applicant is Healkee Medical Pte, Ltd.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K232642. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AirKEE T900?

AirKEE T900 is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Healkee Medical Pte, Ltd.. The 510(k) number is K232642.

When did AirKEE T900 receive FDA 510(k) clearance?

AirKEE T900 received FDA 510(k) clearance on 2024-05-23, under 510(k) number K232642.

Who is the listed applicant for AirKEE T900?

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

What is the FDA product code for AirKEE T900?

The FDA product code for AirKEE T900 is FRA.

列明Healkee Medical Pte, 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。

K232933AirKEE P900

官方来源

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