510(k) K121421
- Device
- FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
- Applicant
- FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
- 510(k) number
- K121421
- Product code
- ONW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-01-17
- Date received
- 2012-05-14
- Regulation
- 876.5860
- Classification name
- Hemodialysis System For Home Use
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLLEEN DURRAN
- Address
- 920 Winter St. Waltham MA US 01854 01854
FDA Registration Numbers#
- 1650907
- 8030665
- 3004111573
- 3015335038
- 1225714
- 9680579
Source Documents#
Other 510(k) Records For Product Code ONW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) | Quanta Dialysis Technologies, Ltd. | 2024-11-01 |
| K124035 | 2008K@HOME HEMODIALYSIS MACHINE | Fresenius Medical Care North America | 2013-07-03 |
| K070049 | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR | Fresenius Medical Care North America | 2011-02-03 |
Legacy Summary#
summary
FDA Review#
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