Cosmo Artificial Intelligence - Ai, Ltd.
Dublin, IE
Cosmo Artificial Intelligence - Ai, Ltd. appears in FDA device records in Dublin, IE. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 6
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 6 510(k) clearances for Cosmo Artificial Intelligence - Ai, Ltd. between 2021 and 2026. The busiest year on record is 2021, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261369 | GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) | QNP | Substantially Equivalent | |
| K241887 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) | QNP | Substantially Equivalent | |
| K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) | QNP | Substantially Equivalent | |
| K231143 | GI Genius System 100 and GI Genius System 200 | QNP | Substantially Equivalent | |
| K211951 | GI Genius | QNP | Substantially Equivalent | |
| DEN200055 | GI Genius | QNP | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain