TYPE FA10 AUDIOMETER— 510(k) K913221

Substantially Equivalent

Frye Electronics, Inc.

FDA 510(k) clearance K913221 for TYPE FA10 AUDIOMETER, Substantially Equivalent on 1991-10-11. Applicant: Frye Electronics, Inc..

Clearance details

Applicant: Frye Electronics, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1991-07-19
Decision date: 1991-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tigard, OR, 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.