FDA 510(k)

PENTAX 의료 영상 대장경 EC34-i10T 시리즈

K-번호: K180285 · 2018-10-26

결정일2018-10-26

제품 코드FDF

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

PENTAX Medical Video Colonoscope EC34-i10T Series 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 2018-10-26 under 510(k) number K180285. 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 PENTAX Medical Video Colonoscope EC34-i10T Series?

PENTAX Medical Video Colonoscope EC34-i10T Series is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Pentax Medical of America, Inc.. The 510(k) number is K180285.

When did PENTAX Medical Video Colonoscope EC34-i10T Series receive FDA 510(k) clearance?

PENTAX Medical Video Colonoscope EC34-i10T Series received FDA 510(k) clearance on 2018-10-26, under 510(k) number K180285.

Who is the listed applicant for PENTAX Medical Video Colonoscope EC34-i10T Series?

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 Medical Video Colonoscope EC34-i10T Series?

The FDA product code for PENTAX Medical Video Colonoscope EC34-i10T Series is FDF.

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

K180292펜택스 비디오 상부 대장내시경 EG34-i10

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