The following data is part of a premarket notification filed by Draeger Medical B.v. with the FDA for Carina Home.
| Device ID | K060705 |
| 510k Number | K060705 |
| Device Name: | CARINA HOME |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAEGER MEDICAL B.V. 3135 Quarry Road Telford, PA 18969 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante 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 | 2006-03-16 |
| Decision Date | 2006-06-14 |
| Summary: | summary |