510(k) Report

Devices descending from K072016

6 later devices reach Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.20260—
+1K254183MR Conditional Cup ElectrodesTechnomed Europe20260—
+1K192564Disposable Gold Cup EEG ElectrodesDymedix Diagnostics, Inc.20201—
+1K190416Dome ElectrodeCoapt, LLC201911
+2K223605ControlSeal Electrode (ELSB)Coapt202201
+2K213884Disposable EEG cableShenzhen Changke Connect Electronics Co., Ltd.20220—