510(k) Report

Devices descending from K061908

19 later devices reach Nicoletone System V32 Amplifier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143233Mitsar-EEGMitsar Co., Ltd.201511—
+1K103140Nicolet Wireless EegCarefusion 209, Inc.201171
+1K092625Wavestate NeuromonitorWavestate, Inc.20100—
+2K231457SPARK ScanSpark Neuro, Inc.20230—
+2K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+2K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG20200—
+2K171781eVox SystemEvoke Neuroscience, Inc.20176—
+2K171397Sienna Ultimate Wireless AmplifierEms Handels Gesellschaft M.B.H.20170—
+2K170441ElectroTekMobilemedtek201712
+2K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U.20171—
+2K151600R-40 EEG AmplifierLifelines, Ltd.20151—
+3K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.20260—
+3K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+3K212788Seer HomeSeer Medical Pty, Ltd.202201
+3K192753NeuralScan SystemMedeia, Inc.20203—
+3K172271Trackit T4 EEG AmplifierLifelines, Ltd.20180—
+4K253767UB ERP SystemUniversal Brain20260—
+4K221959Q21Neurofield, Inc.20230—
+4K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—