FDA 510(k)

ResScan 基礎版

K 號：K254104 · 2026-05-27

決定日期2026-05-27

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

ResScan Essentials is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K254104. 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 ResScan Essentials?

ResScan Essentials is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Resmed Corp. The 510(k) number is K254104.

When did ResScan Essentials receive FDA 510(k) clearance?

ResScan Essentials received FDA 510(k) clearance on 2026-05-27, under 510(k) number K254104.

Who is the listed applicant for ResScan Essentials?

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 ResScan Essentials?

The FDA product code for ResScan Essentials is BZD.

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 K251889我的空氣 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：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 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.K252338我的睡眠達示Somnetics International, Inc. (Dba Transcend Inc)

官方來源

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