510(k) Report

Devices descending from K992742

18 later devices reach Neurofax, Model Eeg-1100A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080546Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ANihon Kohden America, Inc.200811—
+1K073491Eeg-1100A Switch BoxNihon Kohden America, Inc.20085—
+2K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…Nihon Kohden Corporation20250—
+2K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+2K131415Live View Panel (LVP)Neurotronics, Inc.20130—
+2K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp.201261
+2K113117Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction BoxNihon Kohden America, Inc.20122—
+2K082629S12X with Esax OptionChatten Associates, Inc.20094—
+3K173684g.Estim PROG.Tec Medical Engineering GmbH20180—
+3K171124Nihon Kohden Wireless Input Unit WEE-1200Nihon Kohden Corporation20170—
+3K151354Cervello STIMBlackrock Neuromed20162—
+3K142774Polysmith Sleep SystemNeurotronics, Inc.20154—
+4K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc.20180—
+4K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc.20181—
+4K180761SD LTM STIM Cortical StimulatorMicromed S.P.A.20181—
+4K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc.20170—
+5K251480PV01 PVDF Effort SensorNeurotronics, LLC20250—
+5K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc.20250—