510(k) Report

Devices descending from K080546

11 later devices reach Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…Nihon Kohden Corporation20250—
+1K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+1K131415Live View Panel (LVP)Neurotronics, Inc.20130—
+1K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp.201261
+1K113117Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction BoxNihon Kohden America, Inc.20122—
+2K171124Nihon Kohden Wireless Input Unit WEE-1200Nihon Kohden Corporation20170—
+2K142774Polysmith Sleep SystemNeurotronics, Inc.20154—
+3K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc.20180—
+3K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc.20181—
+3K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc.20170—
+4K251480PV01 PVDF Effort SensorNeurotronics, LLC20250—