510(k) K122438 ยท CBK Ventilator, Continuous, Facility Use
HAMILTON-MR1
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Nov 20, 2013 |
| Received | Aug 10, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K122438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2016 | Hamilton Medical, Inc. Hamilton-MR1 Ventilator: Catalog# 161010
The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas o Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.