510(k) Report

Devices descending from K112319

16 later devices reach Electro-Cap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243243Delphi MCS Electrode CapQuantalx Neuroscience, Ltd.20250—
+1K211315Comby EEG CapsPamel D.O.O20210—
+1K200162Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd.20209—
+1K171669g.Nautilus PROG.Tec Medical Engineering GmbH20172—
+1K162460WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode ContactsWavi Co.20171—
+2K223086Ceribell Instant EEG HeadcapCeribell, Inc.20233—
+2K210805Ceribell Instant EEG HeadbandCeribell, Inc.20215—
+2K203331Quick-20mCgx, LLC20211—
+2K202913NeuroCap (Model DEC22)Memory MD, Inc.20210—
+3K254033Ceribell Instant EEG HeadsetCeribell, Inc.20261—
+3K251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)Ceribell, Inc.20250—
+3K242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20240—
+3K232210X-trodes System MX-Trodes20240—
+3K232052Ceribell Instant EEG HeadbandCeribell, Inc.20233—
+4K260363Ceribell Brain Monitor HeadbandCeribell, Inc.20260—
+4K251936Ceribell Delirium Monitor SystemCeribell, Inc.20250—