510(k) Report

Devices descending from K191301

8 later devices reach Ceribell Pocket EEG Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251936Ceribell Delirium Monitor SystemCeribell, Inc.20250—
+1K241589Ceribell Seizure Detection SoftwareCeribell, Inc.20251—
+1K240408REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc.20240—
+1K240993encevis (2.1)Ait Austrian Institute of Technology GmbH20242—
+1K223504Ceribell Status Epilepticus MonitorCeribell, Inc.20233—
+2K261712Ceribell EEG Analysis SoftwareCeribell, Inc.20260—
+2K260998Ceribell Neurology Review SoftwareCeribell, Inc.20260—
+2K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.20250—