The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace 1310p Combination Defibrillation, Monitoring & Pacing Electrode.
| Device ID | K980857 |
| 510k Number | K980857 |
| Device Name: | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Contact | Kathleen Selover |
| Correspondent | Kathleen Selover GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-05 |
| Decision Date | 1998-05-12 |
| Summary: | summary |