MODEL 330 SCREENING AUDIOMETER— 510(k) K911689

Substantially Equivalent

Virtual Corp.

FDA 510(k) clearance K911689 for MODEL 330 SCREENING AUDIOMETER, Substantially Equivalent on 1991-10-21. Applicant: Virtual Corp..

Clearance details

Applicant: Virtual Corp.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1991-04-16
Decision date: 1991-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

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.