510(k) Report

Devices descending from K950208

14 later devices reach Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg Measuring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991899Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring System with AccessoriesNihon Kohden America, Inc.1999131
+2K120397Meb-2300A Neuropack Evoked Potential and Emg Measuring SystemNihon Kohden Corp.20121—
+2K051178Mee-1000A NeuromasterNihon Kohden America, Inc.2005101
+3K191700EyeStatBlinktbi, Inc.20190—
+3K142624Neuromaster G1 MEE200Nihon Kohden Corporation20158—
+3K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+4K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+5K230415Cadwell GuardianCadwell Industries, Inc.20230—
+5K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+5K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302