The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kg with the FDA for Evite Xl.
| Device ID | K083050 |
| 510k Number | K083050 |
| Device Name: | EVITE XL |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Contact | Joyce Kilroy |
| Correspondent | Joyce Kilroy DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2008-12-29 |
| Summary: | summary |