510(k) K080602 ยท DRX Electrode, Electrocardiograph
AUDICOR SENSOR, MODELS: 2.0, 3.0
| Applicant | Inovise Medical, Inc., Portland OR, US |
| Decision | Substantially Equivalent, Sep 25, 2008 |
| Received | Mar 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080602
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.