510(k) Report

Devices descending from K013459

20 later devices reach Modification of NC-Stat through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070109Neurometrix AdvanceNeurometrix, Inc.200815—
+1K060584NC-StatNeurometrix, Inc.200618—
+1K041320Modification to NC-StatNeurometrix, Inc.200419—
+2K190536Mediracer NCSMediracer OY20191—
+2K120979Carefusion Nicolet EdxCarefusion 209, Inc.201212—
+2K083818Universal ElectrodesNeurometrix, Inc.20090—
+2K081871Universal ElectrodesNeurometrix, Inc.20081—
+3K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto,20250—
+3K243982Nicolet EDXNatus Neurology Incorporated20250—
+3K172743Natus VikingQuestNatus Neurology Incorporated20170—
+3K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+3K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated20133—
+4K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+4K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated20241—
+4K230415Cadwell GuardianCadwell Industries, Inc.20230—
+4K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+4K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+5K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302