Ceribell Brain Monitor Headband

FDA 510(k) Premarket Notification · Submission K260363 · Applicant: Ceribell, Inc.

Public Record 510(k) Submission Decision Date: 2026-04-03 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K260363.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K260363
Applicant / Sponsor
Device Name
Ceribell Brain Monitor Headband
Product Code
GXY
Decision Date
2026-04-03
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Neurology (NE)
Clearance Type
Abbreviated
Third Party Flag
N
Date Received
2026-02-04

Related Establishments / Registrations

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