The following data is part of a premarket notification filed by Brain Sentinel, Inc. with the FDA for Speac System.
| Device ID | K200276 |
| 510k Number | K200276 |
| Device Name: | SPEAC System |
| Classification | Physiological Signal Based Seizure Monitoring System |
| Applicant | Brain Sentinel, Inc. 8023 Vantage Drive Suite 216 San Antonio, TX 78230 |
| Contact | Richard Waite |
| Correspondent | Richard Waite Brain Sentinel, Inc. 8023 Vantage Drive Suite 216 San Antonio, TX 78230 |
| Product Code | POS |
| CFR Regulation Number | 882.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-04 |
| Decision Date | 2021-02-06 |