Simergent, LLC · Class II · Cleared Oct 2, 2025
| K-number | K250523 |
| Device name | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) |
| Applicant | Simergent, LLC |
| Product code | FKX |
| Device class | Class II |
| Decision date | Oct 2, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.5630 |
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