Name: Predicase
Price: 199 USD

K-number	K251381
Device name	Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
Applicant	Ceribell, Inc.
Product code	GXY
Device class	Class II
Decision date	Oct 31, 2025
Decision	Substantially Equivalent
Regulation	882.1320

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

Everything you need for a 510(k) submission. Nothing you don't.