Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Natus MedicalLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Xltek with 3 510(k) clearances. The most recent is a 510(k) clearance dated Jan 14, 2002: 80 CHANNEL EEG.
| Jan 14, 2002 | 80 CHANNEL EEGK014147 · GWQ | 510(k) clearances |
| Jan 14, 2002 | 84 CHANNEL EEGK014146 · GWQ | 510(k) clearances |
| Dec 8, 2000 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8K002969 · GWF | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
