The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Blood Volume Monitor.
| Device ID | K982926 |
| 510k Number | K982926 |
| Device Name: | FRESENIUS BLOOD VOLUME MONITOR |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 10 OAK POINT Wrentham, MA 02093 |
| Contact | Donald A Lincoln |
| Correspondent | Donald A Lincoln FRESENIUS MEDICAL CARE NORTH AMERICA 10 OAK POINT Wrentham, MA 02093 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-20 |
| Decision Date | 1999-09-03 |
| Summary: | summary |