| K-number | K061515 |
| Device name | RENALSOFT |
| Applicant | Baxter Healthcare Corp |
| Product code | KPF |
| Device class | Class II |
| Decision date | Sep 11, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 876.5630 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov