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 |