FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
EndeavorRx
K Number: DEN200026
·
Decision Jun 15, 2020
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
3
Review Days
60
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Basic Information
- Device Name
- EndeavorRx
- K Number
- DEN200026
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5803
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Applicant
- Akili Interactive Labs, Inc.
- Date Received
- April 16, 2020
- Decision Date
- June 15, 2020
- 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 |
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