COMFORT KEYBOARD SYSTEM— 510(k) K930044

Substantially Equivalent

Health Care Keyboard Co., Inc.

FDA 510(k) clearance K930044 for COMFORT KEYBOARD SYSTEM, Substantially Equivalent on 1994-07-14. Applicant: Health Care Keyboard Co., Inc..

Clearance details

Applicant
Health Care Keyboard Co., Inc.
Product code
Code ILQ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Menomonee Falls, WI, 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.