The following data is part of a premarket notification filed by Edwards Lifesciences Services Gmbh with the FDA for Edwards Aquarius Hemofiltration System, Model Abm 01.
| Device ID | K070320 |
| 510k Number | K070320 |
| Device Name: | EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | EDWARDS LIFESCIENCES SERVICES GMBH BUSINESS & TECHNOLOGY CENTER BESSEMER DRIVE Stevenage, Hertsfordshire, GB Sg1 2dx |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong EDWARDS LIFESCIENCES SERVICES GMBH BUSINESS & TECHNOLOGY CENTER BESSEMER DRIVE Stevenage, Hertsfordshire, GB Sg1 2dx |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-02 |
| Decision Date | 2007-06-07 |
| Summary: | summary |