XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4— 510(k) K001101

Substantially Equivalent

Excel Tech. , Ltd.

FDA 510(k) clearance K001101 for XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4, Substantially Equivalent on 2000-06-30. Applicant: Excel Tech. , Ltd..

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code GWF
Advisory panel: Neurology
Date received: 2000-04-05
Decision date: 2000-06-30
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.