K231337
- 510(k) number
- K231337
- Device name
- EndeavorRx
- Applicant
- Akili Interactive Labs, Inc. MA · US
- Product code
- QFT — Digital Therapeutic Software For Attention Deficit H
- Decision date
- 2023-12-13
- Date received
- 2023-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231337.pdf
Official FDA record: K231337
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.