FDA 510(k)

Irrisept 抗菌傷口灌洗器

K 號：K210536 · 2021-05-28

決定日期2021-05-28

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 Antimicrobial Wound Lavage is the device name listed in this FDA 510(k) record. The listed applicant is Irrimax Corporation. It received FDA 510(k) clearance on 2021-05-28 under 510(k) number K210536. 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 Antimicrobial Wound Lavage?

Irrisept Antimicrobial Wound Lavage is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is Irrimax Corporation. The 510(k) number is K210536.

When did Irrisept Antimicrobial Wound Lavage receive FDA 510(k) clearance?

Irrisept Antimicrobial Wound Lavage received FDA 510(k) clearance on 2021-05-28, under 510(k) number K210536.

Who is the listed applicant for Irrisept Antimicrobial Wound Lavage?

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 Antimicrobial Wound Lavage?

The FDA product code for Irrisept Antimicrobial Wound Lavage is FQH.

其他以 Irrimax Corporation 為申請人之記錄

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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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