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FDA 510(k)

福迪安尼業公司 FRONT-LINE 露天消毒機 FL120，福迪安尼業公司 FRONT-LINE 露天消毒機 FL135

K 號：K213457 · 2022-03-02

申請人Fort Defiance Industries, LLC
決定日期2022-03-02
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

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 is the device name listed in this FDA 510(k) record. The listed applicant is Fort Defiance Industries, LLC. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213457. 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 Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135?

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Fort Defiance Industries, LLC. The 510(k) number is K213457.

When did Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 receive FDA 510(k) clearance?

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213457.

Who is the listed applicant for Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135?

The FDA 510(k) record lists Fort Defiance Industries, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135?

The FDA product code for Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 is FLE.

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其他以 Fort Defiance Industries, LLC 為申請人之記錄

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。

K243801前線頻率殺菌器（FL135）

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。

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官方來源

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