510(k) Report

Devices descending from K053386

14 later devices reach Xltek EMU40 Eeg Headbox, Model PK1072 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163163XLTEK EMU40EX EEG HeadboxNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+1K072382Model I-2000 MonitorInfinite Biomedical Technologies200812—
+2K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc.20106—
+2K082886Zoom-100DCBrainscope Company, Inc.200911—
+3K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc.20155—
+3K131944IEEGJordan Neuroscience, Inc.20140—
+3K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+4K213299Wireless EEG SystemPascall Systems, Inc.20222—
+4K192549Byteflies KitByteflies NV20201—
+4K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+4K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+5K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+5K251550NX01 (NX01)Naox Technologies Sas20250—
+5K240593VEEGix EEG SystemNeuroServo, Inc.20240—