NEBA SYSTEM
FDA 510(k) clearance DEN110019 · decided 2013-07-15
Clearance details
- K-number
- DEN110019
- Device name
- NEBA SYSTEM
- Applicant
- Lexicor Medical Technology, LLC
- Decision
- Unknown
- Date received
- 2011-12-08
- Decision date
- 2013-07-15
- Days to decision
- 585 days
- Clearance type
- Post-NSE
- Product code
- NCG
- Device class
- 2
- Regulation number
- 882.1440
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Augusta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ceribell Delirium Monitor System (K251936) | Ceribell, Inc. | 2025-12-08 |
| DeltaScan Monitor (K222680) | Prolira B.V. | 2023-02-02 |
Recalls involving this device
No recalls on record reference this clearance.