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 |