FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EndeavorOTC
K Number: K233496
·
Decision Jun 14, 2024
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
3
Review Days
228
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Basic Information
- Device Name
- EndeavorOTC
- K Number
- K233496
- 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
- October 30, 2023
- Decision Date
- June 14, 2024
- 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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