FDA 510(k)

Luna® G3 BPAP 25A

K 號：K201620 · 2021-01-29

決定日期2021-01-29

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

Luna® G3 BPAP 25A 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 2021-01-29 under 510(k) number K201620. 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 25A?

Luna® G3 BPAP 25A is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is 3B Medical, Inc.. The 510(k) number is K201620.

When did Luna® G3 BPAP 25A receive FDA 510(k) clearance?

Luna® G3 BPAP 25A received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201620.

Who is the listed applicant for Luna® G3 BPAP 25A?

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 25A?

The FDA product code for Luna® G3 BPAP 25A 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。

K212263Luna G3 BPAP系統 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

在 FDA 資料庫中查看 →

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。