FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EndeavorRx
K Number: K231337
·
Decision Dec 13, 2023
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
3
Review Days
219
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EndeavorRx
- K Number
- K231337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5803
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Akili Interactive Labs, Inc.
- Date Received
- May 8, 2023
- Decision Date
- December 13, 2023
- Product Code
- QFT
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QFT | Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QFT), ordered by most recent decision date.
Prismira
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EndeavorOTC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EndeavorRx
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology