The following data is part of a premarket notification filed by Niko Medical Products with the FDA for Sensi-prema Neonatal Ecg Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801.
| Device ID | K003804 |
| 510k Number | K003804 |
| Device Name: | SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 |
| Classification | Electrode, Electrocardiograph |
| Applicant | NIKO MEDICAL PRODUCTS 6401 MEADOWS WEST Fort Worth, TX 76132 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer NIKO MEDICAL PRODUCTS 6401 MEADOWS WEST Fort Worth, TX 76132 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2001-08-30 |