NII
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Disinfectant, Dialysate Delivery System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Disinfectant intended for reprocessing dialysate delivery systems.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OZONE GENERATOR (K043207) | Ge Infrastructure Water & Process Technologies | 2005-11-04 |
| HEMOCLEAN (K023064) | Krd Co., Ltd. | 2004-04-06 |
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