FDA 510(k)

셋티드 아이 판오로매틱 앵규러리 에ندی오스코피 시스템 - 책임자

K-번호: K160356 · 2016-05-17

결정일2016-05-17

제품 코드FDF

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Third Eye Panoramic Auxiliary Endoscopy System - Resposable is the device name listed in this FDA 510(k) record. The listed applicant is Avantis Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K160356. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Third Eye Panoramic Auxiliary Endoscopy System - Resposable?

Third Eye Panoramic Auxiliary Endoscopy System - Resposable is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Avantis Medical Systems, Inc.. The 510(k) number is K160356.

When did Third Eye Panoramic Auxiliary Endoscopy System - Resposable receive FDA 510(k) clearance?

Third Eye Panoramic Auxiliary Endoscopy System - Resposable received FDA 510(k) clearance on 2016-05-17, under 510(k) number K160356.

Who is the listed applicant for Third Eye Panoramic Auxiliary Endoscopy System - Resposable?

The FDA 510(k) record lists Avantis Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Third Eye Panoramic Auxiliary Endoscopy System - Resposable?

The FDA product code for Third Eye Panoramic Auxiliary Endoscopy System - Resposable is FDF.

공식 출처

FDA 데이터베이스에서 보기 →

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

셋티드 아이 판오로매틱 앵규러리 에ندی오스코피 시스템 - 책임자

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FDF)

공식 출처