The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Hamilton-c6.
| Device ID | K201658 |
| 510k Number | K201658 |
| Device Name: | Hamilton-C6 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Hamilton Medical AG Via Crush 8 Bonaduz, CH 7402 |
| Contact | Annemarie Weideli |
| Correspondent | Annemarie Weideli Hamilton Medical AG Via Crush 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 | 2020-06-18 |
| Decision Date | 2020-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630002808590 | K201658 | 000 |