510(k) Report

Devices descending from K032278

5 later devices reach Ambu Neuroline Single Patient Eeg/EP Cup Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200540BRAINSTREAM Disposable Deep Cup EEG ElectrodesConmed Corporation20200—
+1K122376PMT Truscan Surface ElectrodePmt Corp.20121—
+1K071118Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and…Ives Eeg Solutions, Inc.20072—
+2K171102Ives MR Conditional Cup ElectrodeIves Egg Solutions20170—
+2K163547MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96Neurovirtual USA, Inc.20170—