The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius 2008k @home With Wireless Wetness Detector.
| Device ID | K070049 |
| 510k Number | K070049 |
| Device Name: | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR |
| Classification | Hemodialysis System For Home Use |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 920 WINTER ST. Waltham, MA 02451 -1457 |
| Contact | Janet C Kay |
| Correspondent | Janet C Kay FRESENIUS MEDICAL CARE NORTH AMERICA 920 WINTER ST. Waltham, MA 02451 -1457 |
| Product Code | ONW |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-04 |
| Decision Date | 2011-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100337 | K070049 | 000 |
| 00840861100941 | K070049 | 000 |