BCIwiki (bciwiki.com) — Ceribell, Inc. received an FDA 510(k) decision of Substantially Equivalent for Ceribell Monitor on June 30, 2026, under submission number K261101. The submission followed the Traditional 510(k) clearance pathway.
FDA lists the product under the device classification name Reduced- Montage Standard Electroencephalograph. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. This is one of several Ceribell clearances in the same period; the product line is built around rapid reduced-montage setup for bedside recording in emergency and critical care.