510(k) K950477 ยท DRX Electrode, Electrocardiograph
DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM
| Applicant | Nikomed U.S.A., Inc., Doylestown PA, US |
| Decision | Substantially Equivalent, Nov 6, 1995 |
| Received | Feb 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950477
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.