Eemagine Medical Imaging Solutions GmbH is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Eemagine Medical Imaging Solutions GmbH - FDA 510(k) Cleared Devices
Recent clearances: WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281), visor2 system, Neo
8
Total
8
Cleared
0
Denied
Eemagine Medical Imaging Solutions GmbH has 8 FDA 510(k) cleared medical devices. Based in Mukwonago, US.
Latest FDA clearance: Nov 2024. Active since 2000. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Eemagine Medical Imaging Solutions GmbH Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Quality & Regulatory Associates, LLC, Steve Hesler and Quality and Regulatory Help, LLC.
FDA 510(k) Regulatory Record - Eemagine Medical Imaging Solutions GmbH
8 devices
Cleared
Nov 25, 2024
WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
Neurology
269d
Cleared
Apr 08, 2022
visor2 system
Neurology
444d
Cleared
Jan 30, 2020
Neo
Neurology
112d
Cleared
Mar 30, 2018
eego amplifiers
Neurology
241d
Cleared
Jun 29, 2011
WAVEGUARD (TM) EEG CAP
Neurology
155d
Cleared
Jul 30, 2007
MAXINSIGHT
Neurology
173d
Cleared
Sep 12, 2005
COGNITRACE
Neurology
69d
Cleared
Oct 23, 2000
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
Neurology
61d