The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace 4103 Neonatal Electrode.
| Device ID | K981964 |
| 510k Number | K981964 |
| Device Name: | MEDI-TRACE 4103 NEONATAL ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | GRAPHIC CONTROLS CORP. PO BOX 1274 189 VAN RENSSELAER STREET Buffalo, NY 14240 |
| Contact | Susan Krasny |
| Correspondent | Susan Krasny GRAPHIC CONTROLS CORP. PO BOX 1274 189 VAN RENSSELAER STREET 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 | 1998-06-04 |
| Decision Date | 1998-11-13 |
| Summary: | summary |