510(k) DEN200026
- Device
- EndeavorRx
- Applicant
- Akili Interactive Labs, Inc.
- 510(k) number
- DEN200026
- Product code
- QFT
- Decision
- Unknown (DENG)
- Decision date
- 2020-06-15
- Date received
- 2020-04-16
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Scott Kellogg
- Address
- 125 Broad St., 4th Floor Boston MA US 02110 02110
FDA Registration Numbers#
- 3013341423
Source Documents#
510(k) summary PDF not indicated by FDA