510(k) K070513 ยท CBK Ventilator, Continuous, Facility Use
HAMILTON-G5
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Nov 26, 2007 |
| Received | Feb 22, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070513
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2016 | Hamilton Medical, Inc. Hamilton G5 with software version between v2.41, v2.42, v2.50.
Catalog number: 1590001 and 1590002.
Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and ped Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.