PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
FDA 510(k) clearance K981681 · decided 1998-08-11
Clearance details
- K-number
- K981681
- Device name
- PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
- Applicant
- Gambro Healthcare
- Decision
- Substantially Equivalent
- Date received
- 1998-05-13
- Decision date
- 1998-08-11
- Days to decision
- 90 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Gambro Prisma M100 preset, Part No. 8353486. recall (Z-0705-06) | Gambro Renal Products, Inc. | 2006-04-05 |