K-number	K221861
Device name	FloNavi Endoscopic Fluorescence Imaging System
Applicant	Guangdong Optomedic Technologies, Inc.
Product code	GCJ
Device class	Class II
Decision date	Feb 18, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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FloNavi Endoscopic Fluorescence Imaging System

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