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 a medical device manufactured by Resmed Pty , Ltd.. It received FDA 510(k) clearance on 2026-02-23 under approval 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. It is manufactured by Resmed Pty , Ltd.. The 510(k) number is K251661.
When was Mariana Minerva; Mariana Nimbus approved by the FDA?
Mariana Minerva; Mariana Nimbus received FDA 510(k) clearance on 2026-02-23, under approval number K251661.
What company makes Mariana Minerva; Mariana Nimbus?
Mariana Minerva; Mariana Nimbus is manufactured by Resmed Pty , Ltd..
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 Devices by Resmed Pty , Ltd.
Related Devices (Code: MNS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.