FDA 510(k)

我的空氣

K 號：K251889 · 2026-04-08

決定日期2026-04-08

產品代碼MNS

諮詢委員會AN

決定相當於

器材摘要

myAir is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 2026-04-08 under 510(k) number K251889. 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 myAir?

myAir is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Resmed Corp. The 510(k) number is K251889.

When did myAir receive FDA 510(k) clearance?

myAir received FDA 510(k) clearance on 2026-04-08, under 510(k) number K251889.

Who is the listed applicant for myAir?

FDA 510(k) 記錄中將 Resmed Corp 列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for myAir?

The FDA product code for myAir is MNS. This falls under the Neurology category.

其他以 Resmed Corp 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。

K261360EasyCare Tx 2 K253553歐里安 K254104ResScan 基礎版 K251657個人化治療舒適設置（PTCS）K250624我的空氣 K241939EasyCare Tx 2

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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。

K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661瑪麗安娜·米涅瓦；瑪麗安娜·尼布斯Resmed Pty , Ltd.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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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。