Medical Device Manufacturer · CA , Oakville

Xltek - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2000

Recent clearances: 84 CHANNEL EEG, 80 CHANNEL EEG, XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Xltek Neurology ✕

3 devices

1-3 of 3

Cleared Jan 14, 2002

Neurology · 27d

Cleared Jan 14, 2002

Neurology · 27d

Cleared Dec 08, 2000

XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8

Neurology · 77d