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

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..

Clearance details

Applicant: Vivosonic, Inc.
Product code: Code EWO
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 ↗

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.