The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for 2008h On Line Clearance Monitor.
| Device ID | K961465 |
| 510k Number | K961465 |
| Device Name: | 2008H ON LINE CLEARANCE MONITOR |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Contact | Tom Folden |
| Correspondent | Tom Folden FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-17 |
| Decision Date | 1997-07-03 |
| Summary: | summary |