510(k) K912669— RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM

Substantially Equivalent

Resound Corp.

Clearance details

Applicant: Resound Corp.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1991-06-18
Decision date: 1991-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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.