AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS— 510(k) K031713

Substantially Equivalent

Viasys Healthcare, Inc.

FDA 510(k) clearance K031713 for AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS, Substantially Equivalent on 2003-08-12. Applicant: Viasys Healthcare, Inc..

Clearance details

Applicant: Viasys Healthcare, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2003-06-02
Decision date: 2003-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, WI, 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.