510(k) Report

Devices descending from K853608

25 later devices reach Neurometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072882Pain Vision, Model PS-2100Osachi Co., Ltd.20090—
+1K982359NC-StatNeurometrix, Inc.199821—
+1K980866Medi-DX 7000 CPT with Amrex ElectrodesNeuro-Diagnostic Assoc.19980—
+1K964622Medi-DX 7000Neuro-Diagnostic Assoc.19970—
+2K060584NC-StatNeurometrix, Inc.200618—
+2K041320Modification to NC-StatNeurometrix, Inc.200419—
+2K013459Modification of NC-StatNeurometrix, Inc.200220—
+3K083818Universal ElectrodesNeurometrix, Inc.20090—
+3K081871Universal ElectrodesNeurometrix, Inc.20081—
+3K070109Neurometrix AdvanceNeurometrix, Inc.200815—
+4K190536Mediracer NCSMediracer OY20191—
+4K120979Carefusion Nicolet EdxCarefusion 209, Inc.201212—
+5K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto,20250—
+5K243982Nicolet EDXNatus Neurology Incorporated20250—
+5K172743Natus VikingQuestNatus Neurology Incorporated20170—
+5K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated20133—
+6K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+6K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated20241—
+6K230415Cadwell GuardianCadwell Industries, Inc.20230—
+6K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+6K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+7K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302