Medical Device Manufacturer · CA , Oakville, Ontario

Excel-Tech Ltd. (Xltek) - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2008

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Excel-Tech Ltd. (Xltek) Neurology ✕

5 devices

1-5 of 5

Cleared Feb 14, 2014

Neurology · 287d

Cleared May 08, 2013

OLYMPIC BRAINZ MONITOR

Neurology · 219d

Cleared Jun 29, 2012

Neurology · 154d

Cleared Apr 19, 2011

NATUS SLEEPWORKS, MODEL 104017

Neurology · 804d

Cleared Oct 31, 2008

NEUROLINK IP, MODEL PK1113

Neurology · 134d