Niko Medical Products · Class II · Cleared Aug 30, 2001
| K-number | K003804 |
| Device name | SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 |
| Applicant | Niko Medical Products |
| Product code | DRX |
| Device class | Class II |
| Decision date | Aug 30, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 870.2360 |
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