FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
FDA 510(k) clearance K043244 · decided 2004-12-20
Clearance details
- K-number
- K043244
- Device name
- FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2004-11-23
- Decision date
- 2004-12-20
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hema recall (Z-1106-2014) | Fresenius Medical Care Holdings, Inc. | 2014-02-26 |