Airdog X5循環空氣淨化器(型號KJ300F-X5)
K 號：K211507 · 2022-11-22
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決定日期2022-11-22
產品代碼FRF
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
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) is the device name listed in this FDA 510(k) record. The listed applicant is Beiang Air Tech , Ltd.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K211507. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)?
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Beiang Air Tech , Ltd.. The 510(k) number is K211507.
When did Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) receive FDA 510(k) clearance?
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) received FDA 510(k) clearance on 2022-11-22, under 510(k) number K211507.
Who is the listed applicant for Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)?
The FDA 510(k) record lists Beiang Air Tech , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)?
The FDA product code for Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) is FRF.
相關臨床試驗
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相關器械（代碼：FRF）
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
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