FDA 510(k)

夢幻站2系統，夢幻站2進階系統

K 號：K200480 · 2020-07-10

決定日期2020-07-10

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

DreamStation 2 System, DreamStation 2 Advanced System is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K200480. 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 DreamStation 2 System, DreamStation 2 Advanced System?

DreamStation 2 System, DreamStation 2 Advanced System is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Respironics, Inc.. The 510(k) number is K200480.

When did DreamStation 2 System, DreamStation 2 Advanced System receive FDA 510(k) clearance?

DreamStation 2 System, DreamStation 2 Advanced System received FDA 510(k) clearance on 2020-07-10, under 510(k) number K200480.

Who is the listed applicant for DreamStation 2 System, DreamStation 2 Advanced System?

FDA 510(k) 記錄將Respironics, Inc.列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for DreamStation 2 System, DreamStation 2 Advanced System?

The FDA product code for DreamStation 2 System, DreamStation 2 Advanced System is BZD.

其他以 Respironics, Inc. 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。

K261262Altis 全面罩 K243394AF531 鼻咽腔SE面罩 K231313治療面罩 3100 NC/SP K210844夢幻穿戴矽膠枕型口罩 K210386磁力鼻罩 K202142睡眠裝置 G3

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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 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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