YES-NO VOICE BOX 7011— 510(k) K901029

Substantially Equivalent

Baylor Biomedical Services

FDA 510(k) clearance K901029 for YES-NO VOICE BOX 7011, Substantially Equivalent on 1990-03-13. Applicant: Baylor Biomedical Services.

Clearance details

Applicant: Baylor Biomedical Services
Product code: Code ILQ
Advisory panel: Physical Medicine
Date received: 1990-03-06
Decision date: 1990-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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.