510(k) Report

Devices descending from K070109

15 later devices reach Neurometrix Advance through their predicates, nearest generation first.

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