FDA 510(k)

Mariana Minerva; Mariana Nimbus

K号: K251661 · 2026-02-23

决定日期2026-02-23

产品代码MNS

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Mariana Minerva; Mariana Nimbus is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Pty , Ltd.. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K251661. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Mariana Minerva; Mariana Nimbus?

Mariana Minerva; Mariana Nimbus is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Resmed Pty , Ltd.. The 510(k) number is K251661.

When did Mariana Minerva; Mariana Nimbus receive FDA 510(k) clearance?

Mariana Minerva; Mariana Nimbus received FDA 510(k) clearance on 2026-02-23, under 510(k) number K251661.

Who is the listed applicant for Mariana Minerva; Mariana Nimbus?

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

What is the FDA product code for Mariana Minerva; Mariana Nimbus?

The FDA product code for Mariana Minerva; Mariana Nimbus is MNS. This falls under the Neurology category.

列明Resmed Pty , 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。

K242547AirFit F20 面罩系统；AirFit F20 NM 面罩系统 K203126S10 Kirra

官方来源

在 FDA 数据库中查看 →

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。