FDA 510(k)

MiniSpacer® 1024、1025、1543 及 1024A、1025A、1543A 兩用噴霧吸入器適配器

K 號：K233553 · 2024-06-18

決定日期2024-06-18

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter 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 2024-06-18 under 510(k) number K233553. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter?

MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter is a medical device that received FDA 510(k) clearance on 2024-06-18. The listed applicant is Thayer Medical Corporation. The 510(k) number is K233553.

When did MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter receive FDA 510(k) clearance?

MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter received FDA 510(k) clearance on 2024-06-18, under 510(k) number K233553.

Who is the listed applicant for MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter?

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 MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter?

The FDA product code for MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter is CAF.

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。

K210558LiteAire基本雙閥可折疊MDI保持腔 K160109Thayer醫療輕量型雙閥可折疊MDI保持器

相關器械（代碼：CAF）

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。

K254171網狀噴霧器（UN204）；網狀噴霧器（UN205）；網狀噴霧器（UN209）；網狀噴霧器（UN210）Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE 用於噴劑吸入器 (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid 配合 eTrack 系統Pari Respiratory Equipment, Inc.K251659網狀霧化器（H6）Qingdao Future Medical Technology Co., Ltd.K244035攜帶式網狀霧化器（JM821）Shenzhen Jermei Medical Device Technology Co., Ltd.K243468壓縮式霧化器（NB-1100）；壓縮式霧化器（NB-1101）；壓縮式霧化器（NB-1102）；壓縮式霧化器（NB-1103）Joytech Healthcare 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。