FDA 510(k)

AeroChamber2go 静電防塵開放式保持室

K 號：K242667 · 2025-01-15

決定日期2025-01-15

產品代碼NVP

諮詢委員會AN

決定相當於

器材摘要

AeroChamber2go Anti-Static Valved Holding Chamber is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2025-01-15 under 510(k) number K242667. The device is classified under product code NVP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AeroChamber2go Anti-Static Valved Holding Chamber?

AeroChamber2go Anti-Static Valved Holding Chamber is a medical device that received FDA 510(k) clearance on 2025-01-15. The listed applicant is Trudell Medical International. The 510(k) number is K242667.

When did AeroChamber2go Anti-Static Valved Holding Chamber receive FDA 510(k) clearance?

AeroChamber2go Anti-Static Valved Holding Chamber received FDA 510(k) clearance on 2025-01-15, under 510(k) number K242667.

Who is the listed applicant for AeroChamber2go Anti-Static Valved Holding Chamber?

The FDA 510(k) record lists Trudell Medical International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AeroChamber2go Anti-Static Valved Holding Chamber?

The FDA product code for AeroChamber2go Anti-Static Valved Holding Chamber is NVP.

其他以 Trudell Medical International 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。

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相關器械（代碼：NVP）

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。

K210558LiteAire基本雙閥可折疊MDI保持腔Thayer Medical Corporation K181649AeroChamber Plus* Flow-Vu* 靜電防塵開放式保持室 (VHC)Trudell Medical International K160109Thayer醫療輕量型雙閥可折疊MDI保持器Thayer Medical Corporation K143615防靜電紧凑空間室Medical Developments International Limited

官方來源

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