The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Hamilton-mr1.
| Device ID | K122438 |
| 510k Number | K122438 |
| Device Name: | HAMILTON-MR1 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, CH Ch-7402 |
| Contact | Ralph Aguila |
| Correspondent | Ralph Aguila HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, CH Ch-7402 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-10 |
| Decision Date | 2013-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630002800761 | K122438 | 000 |