FDA 510(k)

DeVilbiss DV6WM 電子無線调制解調器

K 號：K152810 · 2016-01-21

決定日期2016-01-21

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

DeVilbiss DV6WM Wireless Modem is the device name listed in this FDA 510(k) record. The listed applicant is Devilbiss Healthcare, LLC. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K152810. 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 DeVilbiss DV6WM Wireless Modem?

DeVilbiss DV6WM Wireless Modem is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Devilbiss Healthcare, LLC. The 510(k) number is K152810.

When did DeVilbiss DV6WM Wireless Modem receive FDA 510(k) clearance?

DeVilbiss DV6WM Wireless Modem received FDA 510(k) clearance on 2016-01-21, under 510(k) number K152810.

Who is the listed applicant for DeVilbiss DV6WM Wireless Modem?

The FDA 510(k) record lists Devilbiss Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeVilbiss DV6WM Wireless Modem?

The FDA product code for DeVilbiss DV6WM Wireless Modem is BZD.

其他以 Devilbiss Healthcare, LLC 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。

K253549DeVilbiss 5公升氧濃度濃縮機（555）K250805DeVilbiss PulmO2 10公升氧濃度濃縮機（1060AW）K172648駕馭德維爾比斯 iGo 2 輕便氧氣濃縮器

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。