ARTEMIS LIGHT ENGINE— 510(k) K141164

Name: FDA 510(k) clearance K141164
Creator: U.S. Food and Drug Administration
Published: 2015-03-16

Substantially Equivalent

Quest Medical Imaging

FDA 510(k) clearance K141164 for ARTEMIS LIGHT ENGINE, Substantially Equivalent on 2015-03-16. Applicant: Quest Medical Imaging. Device class: 2.

Clearance details

Applicant: Quest Medical Imaging
Product code: Code NTN
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2014-05-05
Decision date: 2015-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NTN

product code NTN

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.