K912486

Substantially Equivalent

SINGH SPEECH SYSTEM (SERIES 'SSS')

Applicant: Exmoor Plastics , Ltd.
Product code: EWL
Advisory panel: Ear, Nose, Throat
Date received: 1991-06-04
Decision date: 1992-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, GB

Adverse events under product code EWL

product code EWL

Death: 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.