510(k) K090147 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
BLOOD MONITORING UNIT, MODEL BMU 40
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Apr 22, 2009 |
| Received | Jan 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090147
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2020 | Maquet Cardiovascular Us Sales, Llc Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which req Terminated |
DRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.