510(k) K112114 ยท BSZ Gas-Machine, Anesthesia
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
| Applicant | Maquet Critical Care AB, Wayne NJ, US |
| Decision | Substantially Equivalent, Jan 13, 2012 |
| Received | Jul 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112114
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2012 | Maquet Cardiovascular Us Sales, Llc FLOW-I Anesthesia System
The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patient Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.