FDA Product Code
FDA Product Code QJY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243354 | Remunity System | Deka Research & Development Corp. | 2024-11-27 | Special | PDF ↗ |
| K240256 | Remunity System | Deka Research and Development | 2024-06-12 | Traditional | PDF ↗ |
| K202690 | Remunity Pump for Remodulin (treprostinil) Injection | Deka Research and Development | 2020-12-30 | Traditional | PDF ↗ |
| K191313 | Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development | 2020-02-21 | Traditional | PDF ↗ |
Product code QJY · Class II · General Hospital. Data: openFDA.