FloNavi Open Field Fluorescence Imaging System— 510(k) K230407
Substantially EquivalentGuangdong Optomedic Technologies, Inc.
FDA 510(k) clearance K230407 for FloNavi Open Field Fluorescence Imaging System, Substantially Equivalent on 2023-07-17. Applicant: Guangdong Optomedic Technologies, Inc..
Clearance details
- Applicant
- Guangdong Optomedic Technologies, Inc.
- Product code
- Code OWN
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foshan, CN
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.