Name: Predicase
Price: 199 USD

K-number	K252070
Device name	Ceribell Infant Seizure Detection Software
Applicant	Ceribell, Inc.
Product code	OMB
Device class	Class II
Decision date	Nov 21, 2025
Decision	Substantially Equivalent
Regulation	882.1400

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 Infant Seizure Detection Software

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