ASRA, SCREENING AUDIOMETER— 510(k) K914232

Substantially Equivalent

Mercury Electronics (Scot) , Ltd.

FDA 510(k) clearance K914232 for ASRA, SCREENING AUDIOMETER, Substantially Equivalent on 1992-01-31. Applicant: Mercury Electronics (Scot) , Ltd..

Clearance details

Applicant: Mercury Electronics (Scot) , Ltd.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1991-09-20
Decision date: 1992-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glasgow 577 6nu U.K., GB

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.