510(k) K124035
K124035 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "2008K@HOME HEMODIALYSIS MACHINE". The FDA issued a decision of Substantially Equivalent on July 3, 2013. The device falls under product code ONW (Hemodialysis System For Home Use), a Class II device regulated under 21 CFR 876.5860. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2013
- Date Received
- December 28, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemodialysis System For Home Use
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type
To treat and provide hemodialysis therapy at home for chronic renal failure patients.