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

Name: FDA 510(k) clearance K031713
Creator: U.S. Food and Drug Administration
Published: 2003-08-12

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.. Device class: 2.

Clearance details

Applicant: Viasys Healthcare, Inc.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
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 ↗

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K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE2022-06-22
K191372 — Lyra2019-07-15

More clearances from Viasys Healthcare, Inc.

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K060421 — SONARA; SONARA/TEK2006-11-03
K030517 — BALL RECORDING ELECTRODE/STIMULATION PROBE2003-08-01

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.