FDA 510(k)

에비스 엑서라 III 듀오덴비디오스코프 오lympus TJF-Q190V

K-번호: K220587 · 2022-05-11

결정일2022-05-11

제품 코드FDT

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Evis Exera III Duodenovideoscope Olympus TJF-Q190V is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2022-05-11 under 510(k) number K220587. 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 Evis Exera III Duodenovideoscope Olympus TJF-Q190V?

Evis Exera III Duodenovideoscope Olympus TJF-Q190V is a medical device that received FDA 510(k) clearance on 2022-05-11. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K220587.

When did Evis Exera III Duodenovideoscope Olympus TJF-Q190V receive FDA 510(k) clearance?

Evis Exera III Duodenovideoscope Olympus TJF-Q190V received FDA 510(k) clearance on 2022-05-11, under 510(k) number K220587.

Who is the listed applicant for Evis Exera III Duodenovideoscope Olympus TJF-Q190V?

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

What is the FDA product code for Evis Exera III Duodenovideoscope Olympus TJF-Q190V?

The FDA product code for Evis Exera III Duodenovideoscope Olympus TJF-Q190V is FDT.

Olympus Medical Systems Corp.를 신청인으로 등재한 기타 기록

K2620794K 캠에어 헤드 올림푸스 CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, 전동식 잡이형 S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, 전동식 잡이형 S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, 전동식 잡이형 S (TB-0520FCS)K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III 브론코비디오스코프 (OLYMPUS BF-Q190); EVIS EXERA III 브론코비디오스코프 (OLYMPUS BF-H190); EVIS EXERA III 브론코비디오스코프 (OLYMPUS BF-1TH190)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)

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