VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER— 510(k) K033108

Name: FDA 510(k) clearance K033108
Creator: U.S. Food and Drug Administration
Published: 2003-10-27

Substantially Equivalent

Vivosonic, Inc.

FDA 510(k) clearance K033108 for VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER, Substantially Equivalent on 2003-10-27. Applicant: Vivosonic, Inc.. Device class: 2.

Clearance details

Applicant: Vivosonic, Inc.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 2003-09-30
Decision date: 2003-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, On, CA

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.