SPEAC System
FDA 510(k) clearance K182180 · decided 2019-05-11
Clearance details
- K-number
- K182180
- Device name
- SPEAC System
- Applicant
- Brain Sentinel, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-13
- Decision date
- 2019-05-11
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- POS
- Device class
- 2
- Regulation number
- 882.1580
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Antonio, TX, 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 |
|---|---|---|
| Nelli (Version 7.11) (K251506) | Neuro Event Labs OY | 2025-11-21 |
| NightWatch+ US (K243199) | Livassured BV | 2025-07-12 |
| EpiMonitor (K250515) | Empatica S.r.l. | 2025-06-19 |
| EpiWatch Monitoring System (K243515) | Epiwatch, Inc. | 2025-03-07 |
| EpiMonitor (K232915) | Empatica S.r.l. | 2024-02-15 |
| SPEAC System (K200276) | Brain Sentinel, Inc. | 2021-02-06 |
| Embrace (K181861) | Empatica S.r.l. | 2018-12-20 |
| Embrace (K172935) | Empatica S.r.l. | 2018-01-26 |
| Companion (DEN140033) | Lgch, Inc. | 2017-02-16 |
Recalls involving this device
No recalls on record reference this clearance.