510(k) K201658 ยท CBK Ventilator, Continuous, Facility Use
Hamilton-C6
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Dec 11, 2020 |
| Received | Jun 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2025 | Hamilton Medical AG Hamilton C6 REF 160021 (ESM Board PN 10144626
UDI-DI code: 76300028PN160021ZW
Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and option Open, Classified |
CBK | None listed |
| Jun 18, 2024 | Hamilton Medical AG Ventilator HAMILTON-C6, PN: 160021 Open, Classified |
CBK | None listed |
| Apr 25, 2023 | Hamilton Medical AG HAMILTON-C6, REF: 160021 Open, Classified |
CBK | None listed |
| Nov 18, 2022 | Hamilton Medical AG Hamilton-C6 Open, Classified |
CBK | None listed |
| Jun 27, 2022 | Hamilton Medical AG HAMILTON-C6 Intensive Care Ventilator, REF: 160021 Open, Classified |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.