The following data is part of a premarket notification filed by Draeger Medical B.v. with the FDA for Oxylog 2000 Plus System (model 5705080), Oxylog 2000 Plus Basic Device (model 5705082).
| Device ID | K082600 |
| 510k Number | K082600 |
| Device Name: | OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAEGER MEDICAL B.V. 3135 Quarry Road Telford, PA 18969 |
| Contact | Joyce Kilroy |
| Correspondent | Joyce Kilroy DRAEGER MEDICAL B.V. 3135 Quarry Road Telford, PA 18969 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2008-11-26 |
| Summary: | summary |