FDA 510(k)

Irrisept 黏膜清創及清潔系統

K 號：K202222 · 2020-12-14

決定日期2020-12-14

產品代碼FQH

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

Irrisept Wound Debridement and Cleansing System is the device name listed in this FDA 510(k) record. The listed applicant is Irrimax Corporation. It received FDA 510(k) clearance on 2020-12-14 under 510(k) number K202222. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Irrisept Wound Debridement and Cleansing System?

Irrisept Wound Debridement and Cleansing System is a medical device that received FDA 510(k) clearance on 2020-12-14. The listed applicant is Irrimax Corporation. The 510(k) number is K202222.

When did Irrisept Wound Debridement and Cleansing System receive FDA 510(k) clearance?

Irrisept Wound Debridement and Cleansing System received FDA 510(k) clearance on 2020-12-14, under 510(k) number K202222.

Who is the listed applicant for Irrisept Wound Debridement and Cleansing System?

The FDA 510(k) record lists Irrimax Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Irrisept Wound Debridement and Cleansing System?

The FDA product code for Irrisept Wound Debridement and Cleansing System is FQH.

其他以 Irrimax Corporation 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。

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相關器械（代碼：FQH）

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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