The following data is part of a premarket notification filed by Shl Telemedicine International Ltd. with the FDA for Cardio Monitor Center Vision; Model S-cv7-00.
| Device ID | K003392 |
| 510k Number | K003392 |
| Device Name: | CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 |
| Classification | Electrocardiograph |
| Applicant | SHL TELEMEDICINE INTERNATIONAL LTD. 90 YIGAL ALON ST. Tel Aviv, IL 67891 |
| Contact | Alroy Irit |
| Correspondent | Alroy Irit 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 | 2000-10-31 |
| Decision Date | 2001-01-25 |