The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Hamilton-c3.
| Device ID | K201306 |
| 510k Number | K201306 |
| Device Name: | HAMILTON-C3 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Hamilton Medical AG Via Crusch 8 Bonaduz, CH 7402 |
| Contact | Simone Haller |
| Correspondent | Simone Haller Hamilton Medical AG Via Crusch 8 Bonaduz, 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 | 2020-05-15 |
| Decision Date | 2021-02-05 |