The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Neonatal Ecg Electrode With Preattached Leadwire.
| Device ID | K945214 |
| 510k Number | K945214 |
| Device Name: | MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE |
| Classification | Electrode, Electrocardiograph |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. Buffalo, NY 14240 |
| Contact | John H Barrett |
| Correspondent | John H Barrett GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. Buffalo, NY 14240 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-25 |
| Decision Date | 1994-11-10 |