510(k) K190205 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 29, 2019 |
| Received | Feb 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190205
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.