510(k) K120670 ยท CBK Ventilator, Continuous, Facility Use
HAMILTON-T1
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Apr 3, 2012 |
| Received | Mar 5, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120670
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2013 | Hamilton Medical Inc HAMILTON-T1 Ventilator with software versions 1.1.2 or lower.
The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.