FDA 510(k)

アイリゼプト準備と清浄システム

K番号: K202222 · 2020-12-14

決定日2020-12-14

製品コードFQH

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてIrrimax Corporationを記載するその他の記録

K240552アイリゼプト抗菌性創傷洗浄 K222804アイリゼプト抗菌性創傷洗浄 K210536アイリゼプト抗菌性創傷洗浄

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