The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kg with the FDA for Carina System, Model 8419350; Carina Basic Device, Model 5704110.
| Device ID | K072885 |
| 510k Number | K072885 |
| Device Name: | CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson DRAEGER MEDICAL AG & CO. KG 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 | 2007-10-09 |
| Decision Date | 2008-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675398516 | K072885 | 000 |
| 04048675425663 | K072885 | 000 |
| 04048675422495 | K072885 | 000 |
| 04048675422334 | K072885 | 000 |
| 04048675422327 | K072885 | 000 |