FDA 510(k)

FloNavi Open Field Fluorescence Imaging System

K-번호: K230407 · 2023-07-17

신청자Guangdong Optomedic Technologies, Inc.

결정일2023-07-17

제품 코드OWN

자문 위원회GU

결정Substantially Equivalent

기기 요약

FloNavi Open Field 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 2023-07-17 under 510(k) number K230407. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FloNavi Open Field Fluorescence Imaging System?

FloNavi Open Field Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K230407.

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

FloNavi Open Field Fluorescence Imaging System received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230407.

Who is the listed applicant for FloNavi Open Field 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 Open Field Fluorescence Imaging System?

The FDA product code for FloNavi Open Field Fluorescence Imaging System is OWN.

Guangdong Optomedic Technologies, Inc.를 신청인으로 등재한 기타 기록

K252318Insufflator (OPTO-IFL1000)K2526973D 래파로스코프 K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)K241530Stellar Imaging System K231342Insufflator (OPTO-IFL1000)K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)

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