510(k) K161465 ยท DQK Computer, Diagnostic, Programmable
CardioConfirm
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Sep 3, 2016 |
| Received | May 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161465
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.