510(k) K140939 ยท CBK Ventilator, Continuous, Facility Use
HAMILTON-T1,HAMILTON-C1
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Sep 2, 2015 |
| Received | Apr 11, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140939
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2018 | Hamilton Medical AG Hamilton-C1 Ventilator Unit
Product Usage:
The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.