Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) - FDA 510(k) C...
Recent clearances: Natus BrainWatch System, ALGO Pro Newborn Hearing Screener (ALGO Pro), RetCam Envision
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Neurology ✕
11 devices
Cleared
Nov 19, 2024
Natus BrainWatch System
Neurology
56d
Cleared
May 18, 2020
Natus NeuroWorks
Neurology
46d
Cleared
Jun 15, 2018
Natus Photic Stimulator
Neurology
171d
Cleared
Jun 14, 2018
Natus Brain Monitor Amplifier
Neurology
133d
Cleared
Mar 14, 2018
Natus NeuroWorks
Neurology
26d
Cleared
Mar 09, 2018
Grass TWin
Neurology
98d
Cleared
Feb 22, 2018
Natus Quantum
Neurology
30d
Cleared
Nov 03, 2017
Comet-PLUS
Neurology
56d
Cleared
Dec 14, 2016
XLTEK EMU40EX EEG Headbox
Neurology
34d
Cleared
Nov 04, 2016
Trex_HD
Neurology
50d
Cleared
Jun 03, 2016
Background Pattern Classification [BPc(TM)]
Neurology
294d