FDA 510(k)

Thayer醫療輕量型雙閥可折疊MDI保持器

K 號：K160109 · 2017-05-19

決定日期2017-05-19

產品代碼NVP

諮詢委員會AN

決定相當於

器材摘要

Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber is the device name listed in this FDA 510(k) record. The listed applicant is Thayer Medical Corporation. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K160109. 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 Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber?

Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Thayer Medical Corporation. The 510(k) number is K160109.

When did Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber receive FDA 510(k) clearance?

Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber received FDA 510(k) clearance on 2017-05-19, under 510(k) number K160109.

Who is the listed applicant for Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber?

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

What is the FDA product code for Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber?

The FDA product code for Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber is NVP.

其他以 Thayer Medical Corporation 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。

K233553MiniSpacer® 1024、1025、1543 及 1024A、1025A、1543A 兩用噴霧吸入器適配器 K210558LiteAire基本雙閥可折疊MDI保持腔

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。

K242667AeroChamber2go 静電防塵開放式保持室Trudell Medical International 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 K143615防靜電紧凑空間室Medical Developments International Limited

官方來源

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