510(k) Report

Devices descending from K183529

9 later devices reach AE-120A EEG Head Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223628NEBA® Compact EEG2R Mobile HeadsetNeba Health, LLC20230—
+1K203827REMIEpitel, Inc.20213—
+1K202334NeuronauteBioserenity Sas20204—
+2K231366Neuronaute PlusBioserenity Sas20231—
+2K230933REMI Remote EEG Monitoring SystemEpitel, Inc.20231—
+2K223644Neuronaute with IceCap 2 & IceCap 2 SmallBioserenity20231—
+3K261101Ceribell MonitorCeribell, Inc.20260—
+3K243185REMI Remote EEG Monitoring SystemEpitel20250—
+3K243788IceCap product lineBioserenity Medical Devices Group20250—