Class Class II

Ceribell Infant Seizure Detection Software (K252070)

K252070 2025-11-21 Traditional
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Description

Ceribell Infant Seizure Detection Software by Ceribell, Inc., an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252070
Clearance Date2025-11-21
Clearance TypeTraditional
Product CodeOMB
Regulation Number882.1400

Categories

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