FDA 510(k)

TNI Clear-Guard™ 3 angled breathing filter (1545020)

K-번호: K223258 · 2023-06-15

결정일2023-06-15

제품 코드CAH

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

TNI Clear-Guard™ 3 angled breathing filter (1545020) is the device name listed in this FDA 510(k) record. The listed applicant is Intersurgical , Ltd.. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K223258. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TNI Clear-Guard™ 3 angled breathing filter (1545020)?

TNI Clear-Guard™ 3 angled breathing filter (1545020) is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is Intersurgical , Ltd.. The 510(k) number is K223258.

When did TNI Clear-Guard™ 3 angled breathing filter (1545020) receive FDA 510(k) clearance?

TNI Clear-Guard™ 3 angled breathing filter (1545020) received FDA 510(k) clearance on 2023-06-15, under 510(k) number K223258.

Who is the listed applicant for TNI Clear-Guard™ 3 angled breathing filter (1545020)?

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

What is the FDA product code for TNI Clear-Guard™ 3 angled breathing filter (1545020)?

The FDA product code for TNI Clear-Guard™ 3 angled breathing filter (1545020) is CAH.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

TNI Clear-Guard™ 3 angled breathing filter (1545020)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: CAH)

공식 출처