The following data is part of a premarket notification filed by Draeger Medical Gmbh with the FDA for Smartpilot View Model Mk04500.
| Device ID | K103035 |
| 510k Number | K103035 |
| Device Name: | SMARTPILOT VIEW MODEL MK04500 |
| Classification | Gas-machine, Anesthesia |
| Applicant | DRAEGER MEDICAL GMBH 3135 Quarry Road Telford, PA 18969 |
| Contact | Joyce Kilroy |
| Correspondent | Joyce Kilroy DRAEGER MEDICAL GMBH 3135 Quarry Road Telford, PA 18969 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-13 |
| Decision Date | 2012-03-28 |
| Summary: | summary |