FDA 510(k)

Q 비스테리올 성인 유연한 대장경(G-100); Q 베이스 재사용 가능한 베이스 유닛(Q-100)

K-번호: K232028 · 2023-11-17

결정일2023-11-17

제품 코드FDS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is the device name listed in this FDA 510(k) record. The listed applicant is Iq Endoscopes Limited. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K232028. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Iq Endoscopes Limited. The 510(k) number is K232028.

When did Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) receive FDA 510(k) clearance?

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) received FDA 510(k) clearance on 2023-11-17, under 510(k) number K232028.

Who is the listed applicant for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

The FDA 510(k) record lists Iq Endoscopes Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

The FDA product code for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is FDS.

공식 출처

FDA 데이터베이스에서 보기 →

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

Q 비스테리올 성인 유연한 대장경(G-100); Q 베이스 재사용 가능한 베이스 유닛(Q-100)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FDS)

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