ViroZap 室內空氣淨化器，風管型號 1008
K 號：K241140 · 2024-08-01
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決定日期2024-08-01
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
ViroZap Indoor Air Purifier, In Duct Model 1008 is the device name listed in this FDA 510(k) record. The listed applicant is Applied Photonix, LLC. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K241140. 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 ViroZap Indoor Air Purifier, In Duct Model 1008?
ViroZap Indoor Air Purifier, In Duct Model 1008 is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Applied Photonix, LLC. The 510(k) number is K241140.
When did ViroZap Indoor Air Purifier, In Duct Model 1008 receive FDA 510(k) clearance?
ViroZap Indoor Air Purifier, In Duct Model 1008 received FDA 510(k) clearance on 2024-08-01, under 510(k) number K241140.
Who is the listed applicant for ViroZap Indoor Air Purifier, In Duct Model 1008?
The FDA 510(k) record lists Applied Photonix, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ViroZap Indoor Air Purifier, In Duct Model 1008?
The FDA product code for ViroZap Indoor Air Purifier, In Duct Model 1008 is FRA.
相關臨床試驗
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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
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