510(k) Report

Devices descending from K203827

3 later devices reach REMI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230933REMI Remote EEG Monitoring SystemEpitel, Inc.20231—
+1K223628NEBA® Compact EEG2R Mobile HeadsetNeba Health, LLC20230—
+2K243185REMI Remote EEG Monitoring SystemEpitel20250—