510(k) Report

Devices descending from K170363

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261101Ceribell MonitorCeribell, Inc.20260—
+1K242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20240—
+1K242306SignalNED System (Model RE)Forest Devices, Inc.20241—
+1K221563Neurosteer EEG RecorderNeurosteer, Inc.20222—
+1K203827REMIEpitel, Inc.20213—
+1K191301Ceribell Pocket EEG DeviceCeribell, Inc.20198—
+1K183529AE-120A EEG Head SetNihon Kohden Corporation20199—
+2K251936Ceribell Delirium Monitor SystemCeribell, Inc.20250—
+2K251726SignalNED System (Model RE)Forest Devices, Inc.20250—
+2K241589Ceribell Seizure Detection SoftwareCeribell, Inc.20251—
+2K240408REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc.20240—
+2K232779Quex ED; Quex SQx World, Ltd.20240—
+2K240993encevis (2.1)Ait Austrian Institute of Technology GmbH20242—
+2K240593VEEGix EEG SystemNeuroServo, Inc.20240—
+2K230933REMI Remote EEG Monitoring SystemEpitel, Inc.20231—
+2K223504Ceribell Status Epilepticus MonitorCeribell, Inc.20233—
+2K223628NEBA® Compact EEG2R Mobile HeadsetNeba Health, LLC20230—
+2K202334NeuronauteBioserenity Sas20204—
+3K261712Ceribell EEG Analysis SoftwareCeribell, Inc.20260—
+3K260998Ceribell Neurology Review SoftwareCeribell, Inc.20260—
+3K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.20250—
+3K243185REMI Remote EEG Monitoring SystemEpitel20250—
+3K231366Neuronaute PlusBioserenity Sas20231—
+3K223644Neuronaute with IceCap 2 & IceCap 2 SmallBioserenity20231—
+4K243788IceCap product lineBioserenity Medical Devices Group20250—