FRESENIUS LIBERTY CYCLER
FDA 510(k) clearance K043363 · decided 2005-03-31
Clearance details
- K-number
- K043363
- Device name
- FRESENIUS LIBERTY CYCLER
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2004-12-07
- Decision date
- 2005-03-31
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- FKX
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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