510(k) Report

Devices descending from K041198

10 later devices reach NIC36 Amplifier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053606BE Plus / Aura-LTM64 AmplifierEb Neuro S.P.A.20069—
+2K121996BE Plus LTM Amplifier Gwi AmplifierEb Neuro S.P.A.20123—
+2K083577Harmonie SystemStellate Systems201101
+2K101691Lifelines Photic StimulatorLifelines, Ltd.20103—
+3K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…Nihon Kohden Corporation20250—
+3K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.20240—
+3K211974LED PHOTIC SystemMicromed S.P.A.20210—
+3K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20180—
+3K133517Nemus 2 SystemEb Neuro S.P.A.20141—
+4K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.20240—