510(k) K161769 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reprocessed Supreme Diagnostic Electrophysiology Catheters
| Applicant | Innovative Health, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Dec 6, 2016 |
| Received | Jun 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161769
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.