FDA 510(k)

펜택스 비디오 상부 대장내시경 EG34-i10

K-번호: K180292 · 2018-10-12

결정일2018-10-12

제품 코드FDS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

PENTAX Video Upper G.I. Scope EG34-i10 is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical of America, Inc.. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K180292. 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 PENTAX Video Upper G.I. Scope EG34-i10?

PENTAX Video Upper G.I. Scope EG34-i10 is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Pentax Medical of America, Inc.. The 510(k) number is K180292.

When did PENTAX Video Upper G.I. Scope EG34-i10 receive FDA 510(k) clearance?

PENTAX Video Upper G.I. Scope EG34-i10 received FDA 510(k) clearance on 2018-10-12, under 510(k) number K180292.

Who is the listed applicant for PENTAX Video Upper G.I. Scope EG34-i10?

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

What is the FDA product code for PENTAX Video Upper G.I. Scope EG34-i10?

The FDA product code for PENTAX Video Upper G.I. Scope EG34-i10 is FDS.

Pentax Medical of America, Inc.를 신청인으로 등재한 기타 기록

K180285PENTAX 의료 영상 대장경 EC34-i10T 시리즈

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