Ceribell Instant EEG Headcap
FDA 510(k) K223086 · Ceribell, Inc.
510(k) numberK223086
Submission
- Device name
- Ceribell Instant EEG Headcap
- Applicant
- Ceribell, Inc.
Sunnyvale, CA, US - Received
- September 30, 2022
- Decision date
- March 22, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| K232052 | Ceribell Instant EEG HeadbandGXY · Special | 08/08/2023SE |
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Questions and answers
When was Ceribell Instant EEG Headcap cleared by the FDA?
Ceribell Instant EEG Headcap (K223086) received a 510(k) decision of Substantially Equivalent on March 22, 2023, 173 days after the submission was received.
What is the product code of K223086?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.