FDA 510(k)

스마트스타트 에어/워터 및 수술 밸브

K-번호: K160403 · 2016-05-19

결정일2016-05-19

제품 코드ODC

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

SmartStart Air/Water and Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K160403. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SmartStart Air/Water and Suction Valves?

SmartStart Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Endochoice, Inc.. The 510(k) number is K160403.

When did SmartStart Air/Water and Suction Valves receive FDA 510(k) clearance?

SmartStart Air/Water and Suction Valves received FDA 510(k) clearance on 2016-05-19, under 510(k) number K160403.

Who is the listed applicant for SmartStart Air/Water and Suction Valves?

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

What is the FDA product code for SmartStart Air/Water and Suction Valves?

The FDA product code for SmartStart Air/Water and Suction Valves is ODC.

Endochoice, Inc.를 신청인으로 등재한 기타 기록

K160275퍼스널 엔도스코프 시스템 및 퍼스널박스 프로세서와 결합된 퍼스널 엔도스코프 시스템 K161482엔도셋 워터 본트 캡 이리게이션 시스템 K161167시ール 싱글 유즈 바이오플리브 밸브 K153588엔도셋 워터병 캡 시스템 K151475엔도셀셋 셀렉트 주사針

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