FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)— 510(k) K121421
Substantially EquivalentFresenius Medical Care North America, Design Cente
FDA 510(k) clearance K121421 for FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT), Substantially Equivalent on 2013-01-17. Applicant: Fresenius Medical Care North America, Design Cente.
Clearance details
- Applicant
- Fresenius Medical Care North America, Design Cente
- Product code
- Code ONW
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waltham, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.