Cosmo Artificial Intelligence - Ai, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241887 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI | July 25, 2024 |
| K233964 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | January 12, 2024 |
| K231143 | GI Genius System 100 and GI Genius System 200 | May 19, 2023 |
| K211951 | GI Genius | July 23, 2021 |
| DEN200055 | GI Genius | April 9, 2021 |