Device Listing 1133771470
Listing Summary#
- Listing key
- 1133771470
- Premarket submission
- K250523
- Device
- 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
- Decision date
- 2025-10-02