510(k) Report

Devices descending from K210805

5 later devices reach Ceribell Instant EEG Headband through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20240—
+1K232052Ceribell Instant EEG HeadbandCeribell, Inc.20233—
+2K260363Ceribell Brain Monitor HeadbandCeribell, Inc.20260—
+2K254033Ceribell Instant EEG HeadsetCeribell, Inc.20261—
+2K251936Ceribell Delirium Monitor SystemCeribell, Inc.20250—