510(k) K163283 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Sep 20, 2017 |
| Received | Nov 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163283
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2021 | Hamilton Medical AG HAMILTON-H900 Humidifier, Models: 950001, 950004 Completed |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.