The following data is part of a De Novo classification by Lgch, Inc with the FDA for Companion.
| DeNovo ID | DEN140033 |
| Device Name: | Companion |
| Classification | Physiological Signal Based Seizure Monitoring System |
| Applicant | LGCH, INC 115 N Loop, 1604 E.,suite 1203 San Antonio, TX 78232 |
| Contact | Mike Girouard |
| Product Code | POS |
| CFR Regulation Number | 882.1580 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2014-11-10 |
| Decision Date | 2017-02-16 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B481SPC150 | DEN140033 | 000 |