2008K@HOME HEMODIALYSIS MACHINE— 510(k) K124035
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K124035 for 2008K@HOME HEMODIALYSIS MACHINE, Substantially Equivalent on 2013-07-03. Applicant: Fresenius Medical Care North America. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code ONW
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code ONW
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