Ceribell Delirium Monitor System— 510(k) K251936

Name: FDA 510(k) clearance K251936
Creator: U.S. Food and Drug Administration
Published: 2025-12-08

Substantially Equivalent

Ceribell, Inc.

FDA 510(k) clearance K251936 for Ceribell Delirium Monitor System, Substantially Equivalent on 2025-12-08. Applicant: Ceribell, Inc.. Device class: 2.

Clearance details

Applicant: Ceribell, Inc.
Product code: Code NCG
Device class: Class 2
Regulation: 21 CFR 882.1440
Advisory panel: Neurology
Date received: 2025-06-24
Decision date: 2025-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NCG

view all

K222680 — DeltaScan Monitor2023-02-02
DEN110019 — NEBA SYSTEM2013-07-15

More clearances from Ceribell, Inc.

view all

K261101 — Ceribell Monitor2026-06-30
K260998 — Ceribell Neurology Review Software2026-06-24
K260363 — Ceribell Brain Monitor Headband2026-04-03
K254033 — Ceribell Instant EEG Headset2026-02-09
K252070 — Ceribell Infant Seizure Detection Software2025-11-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.