FDA Product Code
FDA Product Code FII — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5860
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K030470 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2003-07-07 | Traditional | PDF ↗ |
| K881270 | GAMBRO MULTIPURPOSE SYSTEM MPS-10 | Gambro, Inc. | 1988-08-24 | Traditional | PDF ↗ |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | Travenol Laboratories, S.A. | 1987-10-13 | Traditional | PDF ↗ |
| K862716 | HEMOFILTRATION SYSTEM 10 | Gambro, Inc. | 1986-09-09 | Traditional | PDF ↗ |
| K822386 | COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA | Hospal Medical Corp. | 1982-10-06 | Traditional | PDF ↗ |
Product code FII · Class II · Gastroenterology, Urology. Data: openFDA.