The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Icare Monitoring System.
| Device ID | K021060 |
| 510k Number | K021060 |
| Device Name: | FRESENIUS ICARE MONITORING SYSTEM |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Contact | Nichole Riek |
| Correspondent | Nichole Riek FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-02 |
| Decision Date | 2002-11-13 |
| Summary: | summary |