FloNavi Open Field Fluorescence Imaging System
K-Number: K230407 · 2023-07-17
Decision Date2023-07-17
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
FloNavi Open Field Fluorescence Imaging System is a medical device manufactured by Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2023-07-17 under approval number K230407. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Guangdong Optomedic Technologies, Inc.. The 510(k) number is K230407.
When was FloNavi Open Field Fluorescence Imaging System approved by the FDA?
FloNavi Open Field Fluorescence Imaging System received FDA 510(k) clearance on 2023-07-17, under approval number K230407.
What company makes FloNavi Open Field Fluorescence Imaging System?
FloNavi Open Field Fluorescence Imaging System is manufactured by Guangdong Optomedic Technologies, Inc..
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.
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Other Devices by Guangdong Optomedic Technologies, Inc.
K231342Insufflator (OPTO-IFL1000)
K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
K221861FloNavi Endoscopic Fluorescence Imaging System
K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
K241530Stellar Imaging System
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Official Source
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