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FDA 510(k)

Mariana Minerva; Mariana Nimbus

K-Number: K251661 · 2026-02-23

ApplicantResmed Pty , Ltd.
Decision Date2026-02-23
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Resmed Pty , Ltd. as applicant

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Related Devices (Code: MNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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