Ceribell Instant EEG Headcap (Small: C251, Medium: C252)— 510(k) K251381

Substantially Equivalent

Ceribell, Inc.

FDA 510(k) clearance K251381 for Ceribell Instant EEG Headcap (Small: C251, Medium: C252), Substantially Equivalent on 2025-10-31. Applicant: Ceribell, Inc.. Device class: 2.

Clearance details

Applicant
Ceribell, Inc.
Product code
Code GXY
Device class
Class 2
Regulation
21 CFR 882.1320
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Sunnyvale, CA, US
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