NeuroMatch
FDA 510(k) clearance K241390 · decided 2024-11-26
Clearance details
- K-number
- K241390
- Device name
- NeuroMatch
- Applicant
- LVIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-05-15
- Decision date
- 2024-11-26
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- OMB
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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| Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (K242446) | Persyst Development Corporation | 2025-01-22 |
| 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.