The following data is part of a premarket notification filed by Nikomed U.s.a., Inc. with the FDA for Disposable Ecg Monitoring Electrode #4570 38x60mm.
| Device ID | K950478 |
| 510k Number | K950478 |
| Device Name: | DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM |
| Classification | Electrode, Electrocardiograph |
| Applicant | NIKOMED U.S.A., INC. 206 AIRPORT BLVD. Doylestown, PA 18901 |
| Contact | Donald C Epstein |
| Correspondent | Donald C Epstein NIKOMED U.S.A., INC. 206 AIRPORT BLVD. Doylestown, PA 18901 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-03 |
| Decision Date | 1995-11-06 |