Medical Device Manufacturer · CA , Oakville

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

13 submissions · 13 cleared · Since 2016
13
Total
13
Cleared
0
Denied

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) — FDA 510(k) Submissions

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) has submitted 13 FDA 510(k) premarket notifications since 2016, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Full-montage Standard Electroencephalograph, Standard Polysomnograph With Electroencephalograph, Automatic Event Detection Software For Full-montage Electroencephalograph, Stimulator, Photic, Evoked Response, Camera, Ophthalmic, Ac-powered . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
Natus BrainWatch System
K242930 · OMC Reduced- Montage Standard... · Neurology
Nov 2024 56d
ALGO Pro Newborn Hearing Screener (ALGO Pro)
K233649 · GWJ Stimulator, Auditory,... · Ear, Nose, Throat
Mar 2024 115d
RetCam Envision
K203500 · HKI Camera, Ophthalmic,... · Ophthalmic
Apr 2021 134d
Natus NeuroWorks
K200878 · OMB Automatic Event Detection... · Neurology
May 2020 46d
Natus Photic Stimulator
K173936 · GWE Stimulator, Photic,... · Neurology
Jun 2018 171d
Natus Brain Monitor Amplifier
K180290 · GWQ Full-montage Standard... · Neurology
Jun 2018 133d
Natus NeuroWorks
K180421 · OMB Automatic Event Detection... · Neurology
Mar 2018 26d
Grass TWin
K173690 · OLV Standard Polysomnograph... · Neurology
Mar 2018 98d
Natus Quantum
K180181 · GWQ Full-montage Standard... · Neurology
Feb 2018 30d
Comet-PLUS
K172711 · OLV Standard Polysomnograph... · Neurology
Nov 2017 56d
XLTEK EMU40EX EEG Headbox
K163163 · GWQ Full-montage Standard... · Neurology
Dec 2016 34d
Trex_HD
K162595 · GWQ Full-montage Standard... · Neurology
Nov 2016 50d
Background Pattern Classification [BPc(TM)]
K152301 · OMA Amplitude-integrated... · Neurology
Jun 2016 294d
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