XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8— 510(k) K002969

Substantially Equivalent

Xltek

FDA 510(k) clearance K002969 for XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8, Substantially Equivalent on 2000-12-08. Applicant: Xltek.

Clearance details

Applicant: Xltek
Product code: Code GWF
Advisory panel: Neurology
Date received: 2000-09-22
Decision date: 2000-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

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.