510(k) K910796— COMPANION SPEECH AID, MODEL 432

Substantially Equivalent

Companion Products Intl.

Clearance details

Applicant: Companion Products Intl.
Product code: Code ILQ
Advisory panel: Physical Medicine
Date received: 1991-02-26
Decision date: 1991-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coyote, CA, US

Adverse events under product code ILQ

product code ILQ

Death: 4
Malfunction: 477
Total: 481

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.