510(k) K003804 ยท DRX Electrode, Electrocardiograph
SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
| Applicant | Niko Medical Products, Fort Worth TX, US |
| Decision | Substantially Equivalent, Aug 30, 2001 |
| Received | Dec 8, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K003804
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.