510(k) K201306 ยท CBK Ventilator, Continuous, Facility Use
HAMILTON-C3
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Feb 5, 2021 |
| Received | May 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201306
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2023 | Hamilton Medical, Inc. HAMILTON C3 Ventilator REF
160005
Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates Open, Classified |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.