FDA 510(k)

瑪麗安娜·米涅瓦；瑪麗安娜·尼布斯

K 號：K251661 · 2026-02-23

決定日期2026-02-23

產品代碼MNS

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 Resmed Pty , Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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

相關器械（代碼：MNS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251889我的空氣Resmed Corp K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K240778Vivo 1, Vivo 2Breas Medical AB K231064ReddyPort 肘關節Smd Manufacturing, LLC K213169BPAP系統BMC Medical Co., Ltd.K171827ReddyPort NIV 接入口肘Smd Manufacturing, LLC

官方來源

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