FDA 510(k)

플로나비 내시경 플루오레스센스 영상 시스템

K-번호: K221861 · 2023-02-18

신청자Guangdong Optomedic Technologies, Inc.

결정일2023-02-18

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

FloNavi Endoscopic Fluorescence Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2023-02-18 under 510(k) number K221861. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FloNavi Endoscopic Fluorescence Imaging System?

FloNavi Endoscopic Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2023-02-18. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K221861.

When did FloNavi Endoscopic Fluorescence Imaging System receive FDA 510(k) clearance?

FloNavi Endoscopic Fluorescence Imaging System received FDA 510(k) clearance on 2023-02-18, under 510(k) number K221861.

Who is the listed applicant for FloNavi Endoscopic Fluorescence Imaging System?

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

What is the FDA product code for FloNavi Endoscopic Fluorescence Imaging System?

The FDA product code for FloNavi Endoscopic Fluorescence Imaging System is GCJ.

Guangdong Optomedic Technologies, Inc.를 신청인으로 등재한 기타 기록

K252318충기(OPTO-IFL1000)K2526973D 래파로스코프 K242513플로나비 내시경 플루오레스센스 이미징 시스템 (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)K241530Stellar Imaging System K231342충기(OPTO-IFL1000)K230407플로나비 오픈 필드 플루오레스센스 이미징 시스템

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