FDA 510(k)

부상된 튜브와 머리piec 액세서리

K-번호: K203400 · 2021-06-14

결정일2021-06-14

제품 코드CAF

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

Corrugated tube with mouthpiece accessory is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2021-06-14 under 510(k) number K203400. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Corrugated tube with mouthpiece accessory?

Corrugated tube with mouthpiece accessory is a medical device that received FDA 510(k) clearance on 2021-06-14. The listed applicant is Trudell Medical International. The 510(k) number is K203400.

When did Corrugated tube with mouthpiece accessory receive FDA 510(k) clearance?

Corrugated tube with mouthpiece accessory received FDA 510(k) clearance on 2021-06-14, under 510(k) number K203400.

Who is the listed applicant for Corrugated tube with mouthpiece accessory?

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

What is the FDA product code for Corrugated tube with mouthpiece accessory?

The FDA product code for Corrugated tube with mouthpiece accessory is CAF.

Trudell Medical International를 신청인으로 등재한 기타 기록

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