510(k) Report

Devices descending from DEN140033

9 later devices reach Companion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182180SPEAC SystemBrain Sentinel, Inc.20191—
+1K172935EmbraceEmpatica S.r.l.20186—
+2K200276SPEAC SystemBrain Sentinel, Inc.20210—
+2K181861EmbraceEmpatica S.r.l.201851
+3K251506Nelli (Version 7.11)Neuro Event Labs OY20250—
+3K243199NightWatch+ USLivassured BV20250—
+3K243515EpiWatch Monitoring SystemEpiwatch, Inc.20250—
+3K232915EpiMonitorEmpatica S.r.l.20241—
+4K250515EpiMonitorEmpatica S.r.l.20250—