The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace 1610c Combination Defibrillation, Monitoring And Pacing Electrode.
| Device ID | K983287 |
| 510k Number | K983287 |
| Device Name: | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND 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 | 1998-09-18 |
| Decision Date | 1998-11-05 |
| Summary: | summary |