510(k) Report

Devices descending from K151929

15 later devices reach Persyst 13 (P13) Eeg Review and Analysis Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231068autoSCOREHolberg Eeg AS20242—
+1K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+1K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+1K191301Ceribell Pocket EEG DeviceCeribell, Inc.20198—
+1K171720encevisAit Austrian Institute of Technology GmbH20186—
+2K251936Ceribell Delirium Monitor SystemCeribell, Inc.20250—
+2K243743autoSCORE (V 2.0.0)Holberg Eeg AS20251—
+2K241589Ceribell Seizure Detection SoftwareCeribell, Inc.20251—
+2K240408REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc.20240—
+2K240993encevis (2.1)Ait Austrian Institute of Technology GmbH20242—
+2K223504Ceribell Status Epilepticus MonitorCeribell, Inc.20233—
+2K211452EncevisAustrian Institute of Technology GmbH20213—
+3K261712Ceribell EEG Analysis SoftwareCeribell, Inc.20260—
+3K260998Ceribell Neurology Review SoftwareCeribell, Inc.20260—
+3K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.20250—