510(k) K921164 ยท DRX Electrode, Electrocardiograph
MODEL 1300 SOFTRACE II ELECTRODE
| Applicant | Medtronic Vascular, Haverhill MA, US |
| Decision | Substantially Equivalent, Mar 18, 1993 |
| Received | Mar 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921164
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.