510(k) Report

Devices descending from DEN110019

2 later devices reach Neba System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222680DeltaScan MonitorProlira B.V.20231—
+2K251936Ceribell Delirium Monitor SystemCeribell, Inc.20250—