FDA 510(k)

PENTAX MEDICAL ED-3490TK, 비디오 양장경

K-번호: K161222 · 2018-02-07

결정일2018-02-07

제품 코드FDT

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

PENTAX MEDICAL ED-3490TK, Video Duodenoscope is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical. It received FDA 510(k) clearance on 2018-02-07 under 510(k) number K161222. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PENTAX MEDICAL ED-3490TK, Video Duodenoscope?

PENTAX MEDICAL ED-3490TK, Video Duodenoscope is a medical device that received FDA 510(k) clearance on 2018-02-07. The listed applicant is Pentax Medical. The 510(k) number is K161222.

When did PENTAX MEDICAL ED-3490TK, Video Duodenoscope receive FDA 510(k) clearance?

PENTAX MEDICAL ED-3490TK, Video Duodenoscope received FDA 510(k) clearance on 2018-02-07, under 510(k) number K161222.

Who is the listed applicant for PENTAX MEDICAL ED-3490TK, Video Duodenoscope?

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

What is the FDA product code for PENTAX MEDICAL ED-3490TK, Video Duodenoscope?

The FDA product code for PENTAX MEDICAL ED-3490TK, Video Duodenoscope is FDT.

Pentax Medical를 신청인으로 등재한 기타 기록

K192280PENTAX 의료 ED-3490TK 비디오 양말 장시경 K171011PENTAX Medical VIVIDEO ENT 비디오스코프 솔루션 K172156PENTAX 의료 EPK-3000 비디오 이미징 시스템 K163614PENTAX Medical ED34-i10T, 비디오 양말장시경

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