EPI K Console— 510(k) K172994

Substantially Equivalent

Moria SA

FDA 510(k) clearance K172994 for EPI K Console, Substantially Equivalent on 2017-10-26. Applicant: Moria SA.

Clearance details

Applicant: Moria SA
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 2017-09-27
Decision date: 2017-10-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Antony, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

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.