Ceribell Instant EEG Headband
K-Number: K232052 · 2023-08-08
ApplicantCeribell, Inc.
Decision Date2023-08-08
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Ceribell Instant EEG Headband is a medical device manufactured by Ceribell, Inc.. It received FDA 510(k) clearance on 2023-08-08 under approval number K232052. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ceribell Instant EEG Headband?
Ceribell Instant EEG Headband is a medical device that received FDA 510(k) clearance on 2023-08-08. It is manufactured by Ceribell, Inc.. The 510(k) number is K232052.
When was Ceribell Instant EEG Headband approved by the FDA?
Ceribell Instant EEG Headband received FDA 510(k) clearance on 2023-08-08, under approval number K232052.
What company makes Ceribell Instant EEG Headband?
Ceribell Instant EEG Headband is manufactured by Ceribell, Inc..
What is the FDA product code for Ceribell Instant EEG Headband?
The FDA product code for Ceribell Instant EEG Headband is GXY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.