The following data is part of a premarket notification filed by Medcon Ltd. with the FDA for Horizon Cardiology Ecg-mckesson's Ecg Management System, Model 1.0.
| Device ID | K061905 |
| 510k Number | K061905 |
| Device Name: | HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MEDCON LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan MEDCON LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-05 |
| Decision Date | 2006-11-08 |
| Summary: | summary |