MODEL 330 SCREENING AUDIOMETER— 510(k) K911689

Name: FDA 510(k) clearance K911689
Creator: U.S. Food and Drug Administration
Published: 1991-10-21

Substantially Equivalent

Virtual Corp.

FDA 510(k) clearance K911689 for MODEL 330 SCREENING AUDIOMETER, Substantially Equivalent on 1991-10-21. Applicant: Virtual Corp.. Device class: 2.

Clearance details

Applicant: Virtual Corp.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
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 ↗

Recent devices under product code EWO

view all

K234095 — OtoNova/OtoNova Pro2024-06-21
K240430 — Otoport Pro2024-03-15
K231545 — hearOAE2023-10-27
K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE2022-06-22
K191372 — Lyra2019-07-15

More clearances from Virtual Corp.

view all

K960500 — THE VIRTUAL M-3321996-04-03
K934715 — MODEL 222 CLINICAL AUDIOMETER1994-05-10
K930203 — MODEL 322 CLINICAL AUDIOMETER1993-07-08
K926574 — MODEL 330 SCREENING AUDIO METER, MODIFIED1993-03-29
K895443 — MODEL 210 IMPEDANCE SYSTEM1990-01-16

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.