FDA 510(k) clearance · back to tracker
FloNavi Open Field Fluorescence Imaging System
Guangdong Optomedic Technologies, Inc. cleared K230407 on 2023-07-17, decision: substantially equivalent
K-number
K230407
Sponsor
Guangdong Optomedic Technologies, Inc.
Device
FloNavi Open Field Fluorescence Imaging System
Class
Class II
Decision
Substantially Equivalent
Decision date
2023-07-17
Product code
OWN
Advisory committee
Gastroenterology, Urology
Medical specialty
Gastroenterology, Urology
Regulation number
876.1500
Official FDA record
Open K230407on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.