FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ceribell Instant EEG Headband
K Number: K210805
·
Decision Aug 30, 2021
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
13
Review Days
166
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Basic Information
- Device Name
- Ceribell Instant EEG Headband
- K Number
- K210805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceribell, Inc.
- Date Received
- March 17, 2021
- Decision Date
- August 30, 2021
- Product Code
- GXY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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Other Clearances by Ceribell, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260363 | Ceribell Brain Monitor Headband | Apr 3, 2026 | Substantially Equivalent |
| K254033 | Ceribell Instant EEG Headset | Feb 9, 2026 | Substantially Equivalent |
| K251936 | Ceribell Delirium Monitor System | Dec 8, 2025 | Substantially Equivalent |
| K252070 | Ceribell Infant Seizure Detection Software | Nov 21, 2025 | Substantially Equivalent |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Oct 31, 2025 | Substantially Equivalent |
| K241589 | Ceribell Seizure Detection Software | Apr 9, 2025 | Substantially Equivalent |
| K232052 | Ceribell Instant EEG Headband | Aug 8, 2023 | Substantially Equivalent |
| K223504 | Ceribell Status Epilepticus Monitor | May 23, 2023 | Substantially Equivalent |
| K223086 | Ceribell Instant EEG Headcap | Mar 22, 2023 | Substantially Equivalent |
| K191301 | Ceribell Pocket EEG Device | Sep 11, 2019 | Substantially Equivalent |