ARTEMIS LIGHT ENGINE— 510(k) K141164
Substantially EquivalentQuest Medical Imaging
FDA 510(k) clearance K141164 for ARTEMIS LIGHT ENGINE, Substantially Equivalent on 2015-03-16. Applicant: Quest Medical Imaging.
Clearance details
- Applicant
- Quest Medical Imaging
- Product code
- Code NTN
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Akron, OH, US
Adverse events under product code NTN
product code NTN- Other
- 1
- Total
- 1
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.