autoSCORE (V 2.0.0)
FDA 510(k) clearance K243743 · decided 2025-04-09
Clearance details
- K-number
- K243743
- Device name
- autoSCORE (V 2.0.0)
- Applicant
- Holberg Eeg AS
- Decision
- Substantially Equivalent
- Date received
- 2024-12-04
- Decision date
- 2025-04-09
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- OMB
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bergen, NO
- Third-party review
- No
- Expedited review
- No
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| NeuroMatch (K241390) | LVIS Corporation | 2024-11-26 |
| REMI-AI Rapid Detection Module (REMI-AI RDM) (K240408) | Epitel, Inc. | 2024-10-17 |
| encevis (2.1) (K240993) | Ait Austrian Institute of Technology GmbH | 2024-09-27 |
| autoSCORE (K231068) | Holberg Eeg AS | 2024-01-07 |
| REMI AI Discrete Detection Module (K231779) | Epitel, Inc. | 2024-01-03 |
| LVIS NeuroMatch (K222450) | LVIS Corporation | 2023-06-09 |
| Ceribell Status Epilepticus Monitor (K223504) | Ceribell, Inc. | 2023-05-23 |
Recalls involving this device
No recalls on record reference this clearance.