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. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care North America, Design Cente
- 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
- Special
- Location
- Waltham, MA, US
Recent devices under product code ONW
view allMore clearances from Fresenius Medical Care North America, Design Cente
view allRecalls naming K121421
K-number listed on FDA's recall record- Z-1549-2015 — 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
- Z-1015-2015 — ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121421.
Data sourced from openFDA. This site is unofficial and independent of the FDA.