The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Hamilton-t1, Hamilton-c1.
| Device ID | K181216 |
| 510k Number | K181216 |
| Device Name: | HAMILTON-T1, HAMILTON-C1 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Hamilton Medical AG Via Crusch 8 Bonaduz, CH 7402 |
| Contact | Katrin Vogt |
| Correspondent | Annemarie Weideli Hamilton Medical AG Via Crusch 8 Bonaduz, CH 7402 |
| Product Code | CBK |
| Subsequent Product Code | BZR |
| Subsequent Product Code | DQA |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2019-08-02 |