FKI
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Set, Dialyzer Holder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AMER. BENTLEY HEMOFILTER HOLDER HFH-1 (K843504) | American Bentley | 1984-10-18 |
| PARALLEL PLATE DIALYZER HOLDER (K811292) | Extracorporeal Medical Specialities, Inc. | 1981-06-02 |
| HOLLOW FIBER DIALYZER HOLDER (K802075) | Renal Devices, Inc. | 1980-09-16 |
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