The following data is part of a premarket notification filed by Medcon Ltd. with the FDA for The Tcs-medcon's Telecardiology System.
| Device ID | K974679 |
| 510k Number | K974679 |
| Device Name: | THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | MEDCON LTD. POB 6718 C/O INTL REGULATORY CONSULTANT Efrat, IL 90435 |
| Contact | Eli M Orbach |
| Correspondent | Eli M Orbach MEDCON LTD. POB 6718 C/O INTL REGULATORY CONSULTANT Efrat, IL 90435 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-15 |
| Decision Date | 1998-03-23 |
| Summary: | summary |