EndeavorRx

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

Akili Interactive Labs Inc.

The following data is part of a De Novo classification by Akili Interactive Labs Inc. with the FDA for Endeavorrx.

Pre-market Notification Details

DeNovo IDDEN200026
Device Name:EndeavorRx
ClassificationDevice 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
ContactScott Kellogg
Product CodeQFT
CFR Regulation NumberDevice Classification Under Section 513(f)(2)(De N [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice 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 BoardNeurology
Classification AdvisoryDevice 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
TypeDirect
Date Received2020-04-16
Decision Date2020-06-15
Reclassification Order:Reclassification Order

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