510(k) Report

Devices descending from K200162

9 later devices reach Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223086Ceribell Instant EEG HeadcapCeribell, Inc.20233—
+1K211315Comby EEG CapsPamel D.O.O20210—
+1K210805Ceribell Instant EEG HeadbandCeribell, Inc.20215—
+2K254033Ceribell Instant EEG HeadsetCeribell, Inc.20261—
+2K251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)Ceribell, Inc.20250—
+2K242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20240—
+2K232052Ceribell Instant EEG HeadbandCeribell, Inc.20233—
+3K260363Ceribell Brain Monitor HeadbandCeribell, Inc.20260—
+3K251936Ceribell Delirium Monitor SystemCeribell, Inc.20250—