SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS— 510(k) K802687

Substantially Equivalent

Intelligent Software Systems, Inc.

FDA 510(k) clearance K802687 for SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS, Substantially Equivalent on 1981-02-04. Applicant: Intelligent Software Systems, Inc..

Clearance details

Applicant: Intelligent Software Systems, Inc.
Product code: Code ILQ
Advisory panel: Physical Medicine
Date received: 1980-10-29
Decision date: 1981-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.