PRISMA SYSTEM
FDA 510(k) clearance K010805 · decided 2002-08-06
Clearance details
- K-number
- K010805
- Device name
- PRISMA SYSTEM
- Applicant
- Gambro Renal Products
- Decision
- Substantially Equivalent
- Date received
- 2001-03-16
- Decision date
- 2002-08-06
- Days to decision
- 508 days
- Clearance type
- Abbreviated
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Prisma continuous renal replacement system. recall (Z-1545-05) | Gambro Renal Products | 2005-10-01 |