Airgle 房間空氣淨化器
K 號：K232645 · 2024-02-16
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決定日期2024-02-16
產品代碼FRA
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
Airgle Room Air Purifier is the device name listed in this FDA 510(k) record. The listed applicant is Airgle Corporation. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K232645. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Airgle Room Air Purifier?
Airgle Room Air Purifier is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Airgle Corporation. The 510(k) number is K232645.
When did Airgle Room Air Purifier receive FDA 510(k) clearance?
Airgle Room Air Purifier received FDA 510(k) clearance on 2024-02-16, under 510(k) number K232645.
Who is the listed applicant for Airgle Room Air Purifier?
The FDA 510(k) record lists Airgle Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Airgle Room Air Purifier?
The FDA product code for Airgle Room Air Purifier is FRA.
相關臨床試驗
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。
相關器械（代碼：FRA）
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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