The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for 2008k@home Hemodialysis Machine.
| Device ID | K124035 |
| 510k Number | K124035 |
| Device Name: | 2008K@HOME HEMODIALYSIS MACHINE |
| Classification | Hemodialysis System For Home Use |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Product Code | ONW |
| Subsequent Product Code | KPO |
| Subsequent Product Code | ODX |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-28 |
| Decision Date | 2013-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861100965 | K124035 | 000 |