510(k) K080181 ยท CBK Ventilator, Continuous, Facility Use
MODIFICATION TO GALILEO GOLD
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Jun 24, 2008 |
| Received | Jan 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080181
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.