FDA 510(k)

AirFit F20 面罩系統; AirFit F20 NM 面罩系統

K 號：K242547 · 2025-05-19

決定日期2025-05-19

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

AirFit F20 Mask System; AirFit F20 NM Mask System 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 2025-05-19 under 510(k) number K242547. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AirFit F20 Mask System; AirFit F20 NM Mask System?

AirFit F20 Mask System; AirFit F20 NM Mask System is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Resmed Pty , Ltd.. The 510(k) number is K242547.

When did AirFit F20 Mask System; AirFit F20 NM Mask System receive FDA 510(k) clearance?

AirFit F20 Mask System; AirFit F20 NM Mask System received FDA 510(k) clearance on 2025-05-19, under 510(k) number K242547.

Who is the listed applicant for AirFit F20 Mask System; AirFit F20 NM Mask System?

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 AirFit F20 Mask System; AirFit F20 NM Mask System?

The FDA product code for AirFit F20 Mask System; AirFit F20 NM Mask System is BZD.

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。

K251661瑪麗安娜·米涅瓦；瑪麗安娜·尼布斯 K203126S10 Kirra

相關器械（代碼：BZD）

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。

K261262Altis 全面罩Respironics, Inc.K253044RXiBreeze PAP系統（RXiBreeze 20C）Resvent Medical Technology Co., Ltd.K253553歐里安Resmed Corp K254104ResScan 基礎版Resmed Corp K251920睡眠呼吸中止症呼吸治療面罩：JoyMask 20-B 全面罩，JoyMask 21-B 全面罩Dcstar, Inc.K253166F6S 全面罩 (F6S)；P6S 鼻枕接口 (P6S)BMC Medical Co., Ltd.

官方來源

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