FDA 510(k)

MAC醫療D系列暖被及溶液加熱櫃

K 號：K180842 · 2019-03-05

決定日期2019-03-05

產品代碼LGZ

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

MAC Medical D-Series Blanket and Solution Warming Cabinets is the device name listed in this FDA 510(k) record. The listed applicant is Mac Medical, Inc.. It received FDA 510(k) clearance on 2019-03-05 under 510(k) number K180842. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MAC Medical D-Series Blanket and Solution Warming Cabinets?

MAC Medical D-Series Blanket and Solution Warming Cabinets is a medical device that received FDA 510(k) clearance on 2019-03-05. The listed applicant is Mac Medical, Inc.. The 510(k) number is K180842.

When did MAC Medical D-Series Blanket and Solution Warming Cabinets receive FDA 510(k) clearance?

MAC Medical D-Series Blanket and Solution Warming Cabinets received FDA 510(k) clearance on 2019-03-05, under 510(k) number K180842.

Who is the listed applicant for MAC Medical D-Series Blanket and Solution Warming Cabinets?

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

What is the FDA product code for MAC Medical D-Series Blanket and Solution Warming Cabinets?

The FDA product code for MAC Medical D-Series Blanket and Solution Warming Cabinets is LGZ.

相關器械（代碼：LGZ）

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。

K262532NORMOFLO™ 灌洗液加熱組合及配件（IR-601、IR-501、IR-61、PL-61）ICU Medical K260988°M加熱系統搭配°M工作站Mequ A/S K252636流體精簡系統The Surgical Company International B.V.K251733Fluido®空氣守護系統The Surgical Company International BV (As Tsc Life)K232107°M加溫系統Mequ A/S K211618Fluido 細胞與體液加熱系統The Surgical Company International B.V.

官方來源

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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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LGZ）

官方來源