FDA 510(k)

Luna G3 BPAP系統

K 號：K212263 · 2022-03-25

決定日期2022-03-25

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

Luna G3 BPAP System is the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2022-03-25 under 510(k) number K212263. 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 Luna G3 BPAP System?

Luna G3 BPAP System is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is 3B Medical, Inc.. The 510(k) number is K212263.

When did Luna G3 BPAP System receive FDA 510(k) clearance?

Luna G3 BPAP System received FDA 510(k) clearance on 2022-03-25, under 510(k) number K212263.

Who is the listed applicant for Luna G3 BPAP System?

The FDA 510(k) record lists 3B Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luna G3 BPAP System?

The FDA product code for Luna G3 BPAP System is BZD.

其他以 3B Medical, 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。

K201620Luna® G3 BPAP 25A K200496Aer X K160127iCodeConnect K153387Luna CPAP 及自動CPAP系統

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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