EVOMATIC 8000/4000— 510(k) K843815

Substantially Equivalent

Dantec Electronics, Inc.

FDA 510(k) clearance K843815 for EVOMATIC 8000/4000, Substantially Equivalent on 1985-05-31. Applicant: Dantec Electronics, Inc..

Clearance details

Applicant: Dantec Electronics, Inc.
Product code: Code GWF
Advisory panel: Neurology
Date received: 1984-09-28
Decision date: 1985-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.