510(k) K153046 ยท CBK Ventilator, Continuous, Facility Use
HAMILTON-MR1
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Sep 6, 2016 |
| Received | Oct 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-MR1, REF: 161010, Intensive Care Ventilator Open, Classified |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.