The following data is part of a premarket notification filed by Hamiton Medical Ag with the FDA for Hamilton-g5.
| Device ID | K180295 |
| 510k Number | K180295 |
| Device Name: | Hamilton-G5 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Hamiton Medical AG Via Crusch 8 Bonaduz, CH 7402 |
| Contact | Frederick Bruhschwein-mandic |
| Correspondent | Frederick Bruhschwein-mandic Hamiton 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 | 2018-02-01 |
| Decision Date | 2019-07-30 |
| Summary: | summary |