The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Combination Defibrillation & Ecg Electrode For Physio Control Defibrillators.
| Device ID | K955828 |
| 510k Number | K955828 |
| Device Name: | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271 |
| Contact | Kathleen Selover |
| Correspondent | Kathleen Selover GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 Buafflo, NY 14240 -1271 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-07-25 |