The following data is part of a premarket notification filed by Draeger Medical Gmbh with the FDA for Savina 300 Savina 300, Country Variants.
| Device ID | K121886 |
| 510k Number | K121886 |
| Device Name: | SAVINA 300 SAVINA 300, COUNTRY VARIANTS |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAEGER MEDICAL GMBH 6 TECH DR Andover, MA 01810 |
| Contact | Beth Zis |
| Correspondent | Beth Zis DRAEGER MEDICAL GMBH 6 TECH DR Andover, MA 01810 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-28 |
| Decision Date | 2014-08-08 |
| Summary: | summary |