FDA Product Code
FDA Product Code QFT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 882.5803
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243729 | Prismira | Lumos Labs, Inc. | 2025-06-13 | Traditional | PDF ↗ |
| K233496 | EndeavorOTC | Akili Interactive Labs, Inc. | 2024-06-14 | Traditional | PDF ↗ |
| K231337 | EndeavorRx | Akili Interactive Labs, Inc. | 2023-12-13 | Traditional | PDF ↗ |
| DEN200026 | EndeavorRx | Akili Interactive Labs, Inc. | 2020-06-15 | Direct | — |
Product code QFT · Class II · Obstetrics/Gynecology. Data: openFDA.