VOCAID, ELECTRONIC VOCAL AID— 510(k) K864204

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..

Clearance details

Applicant
Texas Instruments, Inc.
Product code
Code ILQ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lubbock, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ILQ

product code ILQ
Death
4
Malfunction
477
Total
481

Source: openFDA MAUDE database, through . 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.