VOCAID, ELECTRONIC VOCAL AID— 510(k) K864204

Name: FDA 510(k) clearance K864204
Creator: U.S. Food and Drug Administration
Published: 1986-11-14

Substantially Equivalent

Texas Instruments, Inc.

FDA 510(k) clearance K864204 for VOCAID, ELECTRONIC VOCAL AID, Substantially Equivalent on 1986-11-14. Applicant: Texas Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Texas Instruments, Inc.
Product code: Code ILQ
Device class: Class 2
Regulation: 21 CFR 890.3710
Advisory panel: Physical Medicine
Date received: 1986-10-27
Decision date: 1986-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lubbock, TX, US

Download summary PDF View on FDA.gov ↗

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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.