FDA Product Code
FDA Product Code QOH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4150
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN210006 | Hemolung Respiratory Assist System | Alung Technologies, Inc. | 2021-11-13 | Direct | — |
Product code QOH · Class II · Cardiovascular. Data: openFDA.