The following data is part of a premarket notification filed by Shl Telemedicine International Ltd. with the FDA for Cardiovision Software, Model S-cv5-96.
| Device ID | K981807 |
| 510k Number | K981807 |
| Device Name: | CARDIOVISION SOFTWARE, MODEL S-CV5-96 |
| Classification | Electrocardiograph |
| Applicant | SHL TELEMEDICINE INTERNATIONAL LTD. 90 YIGAL ALON ST. Tel Aviv, IL 67891 |
| Contact | Alroy Yariv |
| Correspondent | Alroy Yariv SHL TELEMEDICINE INTERNATIONAL LTD. 90 YIGAL ALON ST. Tel Aviv, IL 67891 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-21 |
| Decision Date | 1998-08-19 |
| Summary: | summary |