The following data is part of a premarket notification filed by Dragerwerk Ag & Co. Kgaa with the FDA for Savina 300.
| Device ID | K180779 |
| 510k Number | K180779 |
| Device Name: | Savina 300 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Dragerwerk AG & CO. KGaA Moislinger Allee 53-55 Lubeck, DE 23558 |
| Contact | Dr. Bettina Mobius |
| Correspondent | Dr. Bettina Mobius Dragerwerk AG & CO. KGaA Moislinger Allee 53-55 Lubeck, DE 23558 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-26 |
| Decision Date | 2019-01-17 |
| Summary: | summary |