Alung Technologies Inc
FDA Regulatory Profile
Alung Technologies Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0938-2021, Class II) was initiated on December 18, 2020. Its most recent 510(k) clearance was granted on November 13, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0938-2021 | Class II | ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA | December 18, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN210006 | Hemolung Respiratory Assist System | November 13, 2021 |