510(k) K110693 ยท KRE Analyzer, Pacemaker Generator Function, Indirect
PACEART OPTIMA SYSTEM SOFTWARE
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Jun 8, 2011 |
| Received | Mar 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110693
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.