510(k) Report

Devices descending from K802637

22 later devices reach Teca Model-10 Electromyograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060584NC-StatNeurometrix, Inc.200618—
+1K041320Modification to NC-StatNeurometrix, Inc.200419—
+1K013459Modification of NC-StatNeurometrix, Inc.200220—
+1K982359NC-StatNeurometrix, Inc.199821—
+2K083818Universal ElectrodesNeurometrix, Inc.20090—
+2K081871Universal ElectrodesNeurometrix, Inc.20081—
+2K070109Neurometrix AdvanceNeurometrix, Inc.200815—
+3K190536Mediracer NCSMediracer OY20191—
+3K120979Carefusion Nicolet EdxCarefusion 209, Inc.201212—
+4K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto,20250—
+4K243982Nicolet EDXNatus Neurology Incorporated20250—
+4K172743Natus VikingQuestNatus Neurology Incorporated20170—
+4K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+4K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated20133—
+5K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+5K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated20241—
+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