The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Raphael Color Asv Ventilator.
| Device ID | K071194 |
| 510k Number | K071194 |
| Device Name: | RAPHAEL COLOR ASV VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, CH Ch-7402 |
| Contact | Joerg Schneider |
| Correspondent | Joerg Schneider HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, CH Ch-7402 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-30 |
| Decision Date | 2007-10-18 |
| Summary: | summary |