FDA 510(k)

이리세프 상처 제거 및 청소 시스템

K-번호: K202222 · 2020-12-14

결정일2020-12-14

제품 코드FQH

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Irrimax Corporation를 신청인으로 등재한 기타 기록

K240552이리세프 항균 상처 씻기장치 K222804이리세프 항균 상처 씻기장치 K210536이리세프 항균 상처 씻기장치

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