The following data is part of a premarket notification filed by Drager Medical Ag & Co. Kgaa with the FDA for Evitaxl With Option Smartcare.
| Device ID | K051263 |
| 510k Number | K051263 |
| Device Name: | EVITAXL WITH OPTION SMARTCARE |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER MEDICAL AG & CO. KGAA 3135 Quarry Road Telford, PA 18969 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante DRAGER MEDICAL AG & CO. KGAA 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 | 2005-05-16 |
| Decision Date | 2005-07-12 |
| Summary: | summary |