FDA 510(k) Applications for Medical Device Product Code "ONW"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K124035 | FRESENIUS MEDICAL CARE NORTH AMERICA | 2008K@HOME HEMODIALYSIS MACHINE | 07/03/2013 |
K070049 | FRESENIUS MEDICAL CARE NORTH AMERICA | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR | 02/03/2011 |
K121421 | FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) | 01/17/2013 |