510(k) Report

Devices descending from K053606

9 later devices reach BE Plus / Aura-LTM64 Amplifier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121996BE Plus LTM Amplifier Gwi AmplifierEb Neuro S.P.A.20123—
+1K083577Harmonie SystemStellate Systems201101
+1K101691Lifelines Photic StimulatorLifelines, Ltd.20103—
+2K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…Nihon Kohden Corporation20250—
+2K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.20240—
+2K211974LED PHOTIC SystemMicromed S.P.A.20210—
+2K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20180—
+2K133517Nemus 2 SystemEb Neuro S.P.A.20141—
+3K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.20240—