510(k) Report

Devices descending from K092828

24 later devices reach Statnet, Model 3100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172866NeuroCapMemory MD, Inc.20181—
+1K171459Ceribell Instant EEG HeadbandCeribell, Inc.201721—
+2K242306SignalNED System (Model RE)Forest Devices, Inc.20241—
+2K221563Neurosteer EEG RecorderNeurosteer, Inc.20222—
+2K210805Ceribell Instant EEG HeadbandCeribell, Inc.20215—
+2K203827REMIEpitel, Inc.20213—
+2K202913NeuroCap (Model DEC22)Memory MD, Inc.20210—
+2K183529AE-120A EEG Head SetNihon Kohden Corporation20199—
+3K251726SignalNED System (Model RE)Forest Devices, Inc.20250—
+3K242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20240—
+3K232779Quex ED; Quex SQx World, Ltd.20240—
+3K240593VEEGix EEG SystemNeuroServo, Inc.20240—
+3K232052Ceribell Instant EEG HeadbandCeribell, Inc.20233—
+3K230933REMI Remote EEG Monitoring SystemEpitel, Inc.20231—
+3K223628NEBA® Compact EEG2R Mobile HeadsetNeba Health, LLC20230—
+3K202334NeuronauteBioserenity Sas20204—
+4K260363Ceribell Brain Monitor HeadbandCeribell, Inc.20260—
+4K254033Ceribell Instant EEG HeadsetCeribell, Inc.20261—
+4K251936Ceribell Delirium Monitor SystemCeribell, Inc.20250—
+4K243185REMI Remote EEG Monitoring SystemEpitel20250—
+4K231366Neuronaute PlusBioserenity Sas20231—
+4K223644Neuronaute with IceCap 2 & IceCap 2 SmallBioserenity20231—
+5K261101Ceribell MonitorCeribell, Inc.20260—
+5K243788IceCap product lineBioserenity Medical Devices Group20250—