Getinge GSS67N系列蒸氣滅菌器
K 號：K252307 · 2026-01-22
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決定日期2026-01-22
產品代碼FLE
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
Getinge GSS67N Series Steam Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Maquet GmbH (A Getinge Group Company). It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K252307. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Getinge GSS67N Series Steam Sterilizer?
Getinge GSS67N Series Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Maquet GmbH (A Getinge Group Company). The 510(k) number is K252307.
When did Getinge GSS67N Series Steam Sterilizer receive FDA 510(k) clearance?
Getinge GSS67N Series Steam Sterilizer received FDA 510(k) clearance on 2026-01-22, under 510(k) number K252307.
Who is the listed applicant for Getinge GSS67N Series Steam Sterilizer?
The FDA 510(k) record lists Maquet GmbH (A Getinge Group Company) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Getinge GSS67N Series Steam Sterilizer?
The FDA product code for Getinge GSS67N Series Steam Sterilizer is FLE.
相關臨床試驗
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相關器械（代碼：FLE）
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。
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。
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