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Bicarby Dialysate RFP-402 (RFP-402-G) +7 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K243786
Identifiers
- 510(k) Number
- K243786 FDA 510(k)
- FDA Product Code
- KPO FDA 510(k)
- Models / Variants
- Bicarby Dialysate RFP-402 (RFP-402-G) FDA 510(k)Bicarby Dialysate RFP-400 (RFP-400-G) FDA 510(k)Bicarby Dialysate RFP-407 (RFP-407-G) FDA 510(k)Bicarby Dialysate RFP-401 (RFP-401-G) FDA 510(k)Bicarby Dialysate RFP-404 (RFP-404-G) FDA 510(k)Bicarby Dialysate RFP-456 (RFP-456-G) FDA 510(k)Ci-Ca Dialysate 2K (RFP-457-G) FDA 510(k)Ci-Ca Dialysate 4K (RFP-458-G) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Bicarby Dialysate RFP-402 (RFP-402-G) +7 more models by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA_510K — listed in FDA 510(k) — 8…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243786 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
Sources (1)
- FDA 510(k) K243786 24 fields · synced Jun 18, 2026