The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Exalis, Software Version 1.15.
| Device ID | K083158 |
| 510k Number | K083158 |
| Device Name: | EXALIS, SOFTWARE VERSION 1.15 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO, INC. 14143 DENVER WEST PARKWAY Lakewood, CO 80401 |
| Contact | Kae Miller |
| Correspondent | Kae Miller GAMBRO, INC. 14143 DENVER WEST PARKWAY Lakewood, CO 80401 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-24 |
| Decision Date | 2009-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332414106126 | K083158 | 000 |
| 07332414106119 | K083158 | 000 |