Centralized Lung Evaluation System (CLES)
Device Facts
| Record ID | P240033 |
|---|---|
| Device Name | Centralized Lung Evaluation System (CLES) |
| Applicant | Lung Bioengineering, Inc. |
| Product Code | PHO |
| Decision Date | Jun 22, 2026 |
| Decision | APPR |
| Device Class | Class 3 |
Regulatory Classification
Identification
Preservation of donor lungs for transplantation.
