CARDIO MONITOR CENTER VISION; MODEL S-CV7-00— 510(k) K003392

Substantially Equivalent

Shl Telemedicine International , Ltd.

FDA 510(k) clearance K003392 for CARDIO MONITOR CENTER VISION; MODEL S-CV7-00, Substantially Equivalent on 2001-01-25. Applicant: Shl Telemedicine International , Ltd..

Clearance details

Applicant: Shl Telemedicine International , Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2000-10-31
Decision date: 2001-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel-Aviv, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.