510(k) K231337
- Device
- EndeavorRx
- Applicant
- Akili Interactive Labs, Inc.
- 510(k) number
- K231337
- Product code
- QFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-13
- Date received
- 2023-05-08
- Regulation
- 882.5803
- Classification name
- Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bhupinder Singh
- Address
- 125 Broad St., 5th Floor Boston, MA US 02110 02110
FDA Registration Numbers#
- 3013341423