510(k) Report

Devices descending from K011204

14 later devices reach Neurofax, Models Eeg-1100A, Eeg-9100A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170441ElectroTekMobilemedtek201712
+1K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+1K022121PSG Input Box, Model JE-912AKNihon Kohden America, Inc.20029—
+2K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—
+2K212788Seer HomeSeer Medical Pty, Ltd.202201
+2K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp.201261
+2K062943Polysmith Sleep System, Model NTI5498Neurotronics, Inc.20077—
+2K050833Electrode Junction Box, Model JE-921ANihon Kohden America, Inc.20057—
+3K142774Polysmith Sleep SystemNeurotronics, Inc.20154—
+3K131415Live View Panel (LVP)Neurotronics, Inc.20130—
+4K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc.20180—
+4K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc.20181—
+4K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc.20170—
+5K251480PV01 PVDF Effort SensorNeurotronics, LLC20250—