The following data is part of a premarket notification filed by Fresenius Medical Care North America, Design Cente with the FDA for Fresenius 2008k Home Hemodialysis Machine With Wireless Wetness Detector (wetalert).
| Device ID | K121421 |
| 510k Number | K121421 |
| Device Name: | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) |
| Classification | Hemodialysis System For Home Use |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE 920 WINTER STREET Waltham, MA 01854 -1457 |
| Contact | Colleen Durran |
| Correspondent | Colleen Durran FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE 920 WINTER STREET Waltham, MA 01854 -1457 |
| Product Code | ONW |
| Subsequent Product Code | KDI |
| Subsequent Product Code | ODX |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-14 |
| Decision Date | 2013-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861101023 | K121421 | 000 |