AUDIO EXPERT AUDIOMETER— 510(k) K942716

Name: FDA 510(k) clearance K942716
Creator: U.S. Food and Drug Administration
Published: 1994-09-02

Substantially Equivalent

Beltone Electronics Corp.

FDA 510(k) clearance K942716 for AUDIO EXPERT AUDIOMETER, Substantially Equivalent on 1994-09-02. Applicant: Beltone Electronics Corp.. Device class: 2.

Clearance details

Applicant: Beltone Electronics Corp.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1994-06-09
Decision date: 1994-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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K954936 — BELTONE ULTIMA 80 OTOSONIC POWER PAS1995-12-06
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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.