Lyra— 510(k) K191372

Name: FDA 510(k) clearance K191372
Creator: U.S. Food and Drug Administration
Published: 2019-07-15

Substantially Equivalent

Interacoustics A/S

FDA 510(k) clearance K191372 for Lyra, Substantially Equivalent on 2019-07-15. Applicant: Interacoustics A/S. Device class: 2.

Clearance details

Applicant: Interacoustics A/S
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 2019-05-22
Decision date: 2019-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middelfart, DK

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

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.