Easyscreen— 510(k) K171506

Substantially Equivalent

Maico Diagnostics GmbH

FDA 510(k) clearance K171506 for Easyscreen, Substantially Equivalent on 2017-08-29. Applicant: Maico Diagnostics GmbH.

Clearance details

Applicant: Maico Diagnostics GmbH
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2017-05-23
Decision date: 2017-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

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.