510(k) K091908 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
M3 MONITOR
| Applicant | Spectrum Medical , Ltd., Gloucester, Gloucesterhsire, GB |
| Decision | Substantially Equivalent, Jul 10, 2009 |
| Received | Jun 25, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091908
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2017 | Zimmer Biomet, Inc. Cobalt HV Bone Cement
Cobalt MV Bone Cement
Cobalt HV Bone Cement With Gentamicin Terminated |
LOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.