FIJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Dialysate Delivery, Recirculating, Single Pass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DIALYSIS MACHINES DM-346 & 346-1 (K772163) | Extracorporeal Medical Specialities, Inc. | 1977-11-28 |
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