The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Raphael Color.
| Device ID | K052863 |
| 510k Number | K052863 |
| Device Name: | RAPHAEL COLOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | HAMILTON MEDICAL AG VIA NOVA Rhaezuens, CH Ch-7403 |
| Contact | Curdin Danuser |
| Correspondent | Curdin Danuser HAMILTON MEDICAL AG VIA NOVA Rhaezuens, CH Ch-7403 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-11 |
| Decision Date | 2006-01-06 |
| Summary: | summary |