| DeNovo ID | DEN200026 |
| Device Name: | EndeavorRx |
| Classification | 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 Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Device Classification Under Section 513(f)(2)(De Novo) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fd |
| Applicant | Akili Interactive Labs Inc. 125 Broad Street, 4th Floor Boston, MA 02110 |
| Contact | Scott Kellogg |
| Product Code | QFT |
| CFR Regulation Number | Device Classification Under Section 513(f)(2)(De N [🔎] |
| 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 | 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 Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Fo |
| Type | Direct |
| Date Received | 2020-04-16 |
| Decision Date | 2020-06-15 |
| Reclassification Order: | Reclassification Order |